Total 22 relationship manager job vacancies in Quality Assurance / Control category in D23 Hillview, Dairy Farm, Bukit Panjang, Choa Chu Kang

About Us

Vivo Surgical is a patient-focused, clinician-driven medical device developer and manufacturer. Headquartered in Singapore with offices in China and Thailand, we are pioneering a novel endoscopic surgical robot for complex endoluminal surgeries. ISO 13485 certified with international accreditations awarded such as the US FDA and European CE mark, our devices target the medical needs of the world through innovative applications of science & technology. These encompass such fields as in vivo surgical LED lighting, portable endoscopy and endoscopic robots, which are strategically co-developed with world-class healthcare institutions and KOL collaborators. Join us as we build towards our vision of being Asia Pacific’s leading medical device developer and manufacturer.

About The Role

We value the importance of having a robust Quality Assurance and Regulatory Affairs team that would serve as a key pillar for sustained commercial success. To that end, we are looking for a Quality Assurance & Regulatory Affairs Manager to join us on this journey. You will be part of our fast-growing team and will take ownership of your role from the get-go. You will work on ensuring our company’s commitment to comply with regulatory requirements and to maintain the effectiveness of our Quality Management System (QMS). You will also be in charge of our products’ regulatory strategies and submissions to various regulatory bodies. Your role will enable you to work not only with diverse functions internally but also in close tandem with our external partners such as our suppliers, distributors and notified bodies.

Your responsibilities shall include the following:

• Ensure the company’s QMS complies with ISO 13485 and FDA 21 CFR 820/QMSR.
• Develop and manage Quality Procedures such as document control, CAPA, NCR, Supplier Control, Production Control, Feedback and Complaints Handling, and Post Market Surveillance.
• Organize and execute internal audits, management reviews and supplier audits.
• Plan and lead ISO 13485 audits and regulatory inspections.
• Participate in the products’ verification and validation activities.
• Develop, review and compile the medical device technical files whilst making sure the products meet all regulatory and quality standards.
• Involved in risk assessment tasks to identify potential quality and compliance risks in the product lifecycle and advise adequate risk control measures.
• Serve as the company’s Quality Management Representative (QMR) and Person Responsible for Regulatory Compliance (PRRC).
• Manage and mentor the QARA team to ensure members are adequately trained.
• Stay updated on medical device laws and regulations in the targeted markets.
• Work with senior management to define and deliver adequate quality and regulatory strategies.

Your Qualifications & Experience

• Minimum Bachelor’s degree in Engineering or Science.
• At least 5 years’ experience in quality assurance and/or regulatory affairs in the medical device Industry.
• Firm understanding of ISO 13485:2016, FDA 21 CFR 820/QMSR and ISO 14971.
• Prior involvement in HSA, FDA 510(k)/De Novo and/or MDR 2017/745 submissions will be a plus.
• Experience in generating risk management documentation (risk management plan, report, FMEAs).
• Possess a leadership and strategic mindset to organize and prioritize tasks for effective and timely delivery of regulatory goals to meet the company’s business objectives.
• Certification as an ISO13485:2016 lead auditor will be advantageous.

Contact

Please send your CV and cover letter to: [email protected]. We look forward to receiving your application.

Overview

The Job Holder will support in building improvement capabilities and culture in the NUHS Regional Health System Office (RHSO), including community partners such as GPs. The Job Holder will be involved in co-developing and conducting quality improvement training for RHSO staff and community partners, as well as facilitate and coach small to large scale improvement projects through the use of appropriate tools/methodologies.

Job Responsibilities

1. Deliver QI Training

• Develop training materials and resources (e.g. training guides and e-learning videos) on quality improvement
• Conduct and facilitate quality improvement training sessions/workshops for RHSO staff and partners
• Gather feedback on training sessions and use of appropriate improvement methodologies/tools
• Deliver training on lean management and human-centred tools to impart knowledge and skills to hospital staff.

1. Facilitation of improvement projects

• Facilitate and coach department/division and organisation-wide level improvement projects to improving quality and processes through the use of appropriate tools/methodologies
• Monitor the progress of improvement activities and guide teams to take appropriate actions
• Assist in interpreting data to measure the effectiveness of the improvement activities

1. Strategy & Culture Building

• Assist in development and implementation of Improvement framework and strategies
• Support initiatives or events that promote improvement and Innovation culture in RHSO
• Lead engagement with HODs to influence and identify areas of improvement in quality and safety

1. Any other tasks as assigned

Requirements

Qualification Required and Area of Discipline

Good degree in any discipline, preferably in Life Sciences, Business Administration, Industrial Design

Prior healthcare sector experience is preferred

Required Competencies and Capabilities (Skills, Experiences and Professional Licences)

• Proficient in quality improvement methodologies such as Lean, process/value-stream mapping, design thinking
• At least 1-2 years of experience in facilitating workshops and conducting trainings
• Confident in coaching and guiding fellow colleagues in Quality Improvement tools
• Certified Six Sigma Green/Black Belt will be an added advantage
• Able to engage stakeholders and work through doctors, nurses, allied health professionals, operations and administrative staff
• Able to work independently and as a team
• Ability to perform even under tight timelines
• Good analytical and organization skills
• Good writing and verbal communication skills
• Open to learning and trying new things. Able to grasp concepts easily and be able to think on the feet.
• Highly self-driven and self-motivated, positive attitude and perseverance to overcome obstacles

DESCRIPTION

The Regulatory Compliance Manager reports to the Project Director and shall be responsible for the effective design effort and coordination of the Sub-Contractor's discipline engineering professionals. The Regulatory Compliance Manager shall ensure that all de-signs comply with the requirements of the Work; that all Work is efficiently and effectively executed in accordance with the criteria, specifications and standards listed in the CONTRACT; and that the designs comply with safe and reasonable standards as accepted within the offshore oil and gas industry. The Regulatory Compliance Manager shall be responsible for his/her scope of work as given below:

DUTIES & RESPONSIBILITIES

• Develop Regulatory Permits & Consents Compliance Plan for the project including all active and passive statutory and Classification compliance requirements.
• Review Compliance Plan with Client and Class Authority, and report as necessary.
• Monitor changes in regulations to ensure the project is designed and installed to satisfy the correct edition of statutory and Classification requirements.
• Inform all disciplines of Regulatory and Classification requirements.
• Monitor the submission of Regulatory Compliance documentation and maintain master file of all Regulatory Permits & Consents.
• Monitor the issue of acceptance or permits by the Regulatory bodies and Classification society.
• Handover Regulatory Permits & Consents Compliance Plan to CLIENT/Operator indicating dates when permits and consents are required to be renewed.
• As necessary, participate with Project Management in negotiation and establishment of contracts for Class review and Regulatory Compliance at bid, FEED, or sanction stages of project.
• Provide Regulatory audit functions for accuracy of PO certification and inspection requirements within Regulatory Compliance scope (Vendor Compliance).
• Collect and promulgate Regulatory lesson learned during project.
• Support project team with respect to availability of appropriate / applicable codes and standards from Company reference library resource.

Comply with HSE requirements:

• Environmental Aspects & Impacts Assessment.
• OHS Hazardous & Risk Assessment.
• Follow HSE Regulations.

REQUIREMENTS

• Minimum educational requirements of a Bachelors’ and/or Masters’ degree in Mechanical / Chemical / petroleum Engineering or equivalent.
• Direct experience working on FPSO projects.
• Experience working with regulatory bodies in West Africa, China, and Europe.
• Minimum 15-18 years’ experience, with Oil & Gas projects (fixed installations and FPSOs), with significant experience working as a Project Manager or Lead Engineer.
• Must have prior work experience with medium/ large sized brownfield and/or greenfield projects in the upstream Oil and Gas sector, in a similar role and possess a good understanding of project phases, milestones, deliverables, internal and external interfaces.
• Good leadership skills to manage and develop a team.

Job Description & Responsibilities:

• Maintenance of Quality Management System ensuring compliance to internal, and international standards and regulatory requirements for medical devices.
• Develop QMS documents in line with business activity of DxD Hub.
• Work with technical team to create quality document related to product design, development and manufacturing, including product test/validation protocols, change management in compliance to applicable regulatory requirements.
• Develop and evaluate medical device regulatory intelligence and maximize opportunities to expedite the registration process within S.E.A region, China and USA. Activities include obtaining and maintaining domestic and regional market access for our innovative products.
• Provide appropriate inputs to assist in defining regulatory strategies and timelines for regulatory submissions for the total product lifecycle for medical devices.
• Compile technical, clinical and production protocols and documentations necessary for new products dossier submission to S.E.A. region, China and USA. regulatory submissions. Liaise with technical team (locally and internationally) on technical information required to prepare submission dossiers. Manage preparation (developing submission content, management of document legalization, and creation of any other documents required for submissions) and maintenance of regulatory submissions and other premarket registrations to acquire appropriate commercial distribution clearances in accordance with regulatory strategic plan.
• Overall responsible for ensuring that medical device files are set up in compliance to regulatory requirement.
• Monitor and communicate new and changing medical device law, guidance regulations in a timely manner. Reviews process change recommendation and assists in implementing new procedures and documentation.
• Ensure that regulatory records are controlled and maintained.
• Train internal and external stakeholders on regulatory data management processes and platforms, regulatory matters and product registration.

Job Requirements:

• Master or Bachelor of Science/Engineering with strong background in biomedical, computer or engineering sciences.
• Possess 3 years or more of working experience in quality assurance and regulatory affairs in medical devices; thorough working knowledge of ISO 13485:2016.
• Good working knowledge in managing QMS in a medical device environment in compliance to ISO 13485:2016.
• Competent in quality assurance methodologies.
• Working knowledge in QA processes for design, development and manufacturing of IVD, SaMD and Integrated Medical Technologies.
• Demonstrated skills in risk management (ISO 14971).
• Knowledge of Health Sciences Authority requirement for IVD product submission.
• Knowledge in regulatory requirements for medical devices in ASEAN, USA and EU.
• Experience with product registration submission and evaluation.
• Experience with maintaining internal regulatory database.
• Experience with Dossier Creation.
• Ability to develop and implement plans for regulatory submission.
• Awareness of applicable workplace environment, health and safety regulations.
• Ability to network and build strategic partnership with good problem solving skills and communication skills.
• Possess leadership and agile mindset.

The above eligibility criteria are not exhaustive. A*STAR may include additional selection criteria based on its prevailing recruitment policies. These policies may be amended from time to time without notice. We regret that only shortlisted candidates will be notified.

COMPANY DESCRIPTION

About BW Group

BW Group is a leading global maritime company involved in shipping, floating infrastructure, deepwater oil & gas production, and new sustainable technologies. Founded in 1955 by Sir YK Pao, BW controls a fleet of over 450 vessels transporting oil, gas and dry commodities, with its 200 LNG and LPG ships constituting the largest gas fleet in the world. In the renewables space, the group has investments in solar, wind, batteries, biofuels and water treatment. BW is proud to be listed as one of Forbes World's Best Employers 2023.

Are you ready to make an impact?

What drives us is our mission to deliver energy for the world today, and to find solutions for tomorrow. If you want to make lives better around the world by providing access to energy, while working on sustainability and decarbonisation, we'd like to hear from you. Working at BW you will feel the pulse of the world each day. If something happens in the world, we feel it, and you can play your part by anticipating and responding to it. Our high-performing teams are drawn to BW by the global nature of our work and the satisfaction of working with collaborative people who inspire each other to deliver exceptional results.

RESPONSIBILITIES

We are seeking a highly skilled and experienced IT Compliance and Cyber Risk Manager to join our dynamic IT team. This role is crucial in ensuring our IT operations comply with IT general controls, SOX controls, and other regulatory requirements. Additionally, the manager will lead our Cyber Risk Quantification Program, identifying and mitigating cyber risks to protect our company's assets and reputation.

Responsibilities:

• Compliance Management:
• Ensure all IT operations comply with IT general controls, SOX controls, and other relevant framworks the company chose to company chose to complay with (e.g. NIST CSF, CERT RMM) regulatory requirements.
• Develop, implement, and maintain IT compliance methodology, policies and procedures.
• Work with your IT colleguaes to ensure compliance with internal and external standards. Lead regular assessment with the IT organisation.
• Collaborate with internal and external auditors to facilitate compliance audits and address findings.

• IT-Risk Management:
• Manage the internal Cyber Risk Quantification Program with the company tools to identify, assess, and quantify cyber risks.
• Monitor and report on the effectiveness of IT risk management initiatives.
• Stay updated on the latest IT Risks, cyber threats and vulnerabilities.

• Policy and Procedure Development:
• Develop and maintain IT compliance and cyber risk management policies and procedures.
• Ensure policies and procedures are communicated effectively to all relevant stakeholders.
• Provide training and guidance to IT staff on compliance and risk management best practices.

• Collaboration and Communication:
• Work closely with other departments to ensure a cohesive approach to IT compliance and cyber risk management.
• Communicate effectively with senior management, providing regular updates on compliance status and IT-Risk management activities.
• Serve as the primary point of contact for IT compliance and risk management issues.

• Bachelor's degree in Information Technology, Computer Science, or a related field.
• Minimum of 5 years of experience in IT compliance, ITGC and/or SOX controls, and IT risk management.
• Strong knowledge of IT general controls, Framworks, and regulatory requirements.
• Experience with IT risk quantification and mitigation strategies.
• Excellent analytical, problem-solving, and communication skills.
• Relevant certifications such as CISA, CISSP, CRISC, or similar are highly desirable.
• Strong communication and interpersonal skills, with the ability to effectively engage with stakeholders at all levels.
• Ability to manage multiple tasks and deadlines in a fast-paced environment
• Eager Learner: Has a strong willingness to learn new things and continuously seeks to improve their skills and knowledge.
• Team Player: Works well in a team and contributes to a positive team environment.
• Problem Solver: Demonstrates strong problem-solving skills, with the ability to think critically and find creative solutions to challenges.
• Detail-Oriented: Pays close attention to detail and has a strong commitment to quality.
• Adaptable: Is flexible, can quickly adapt to new situations and changes in project scope or direction, understand the needs of his peers and contribute to a prefessional and enjoyable work environment.

At BW, we offer challenging work in an international environment with a team of dedicated and competent colleagues. We recognise that the success of BW rests with each employee's ability to provide the necessary skills and confidence within the team, and our training is tailored to suit individual needs and career aspirations.

Vision: Best on Water

Mission: We deliver energy for the world today, and find solutions for tomorrow

Values

• Collaborative
• Ambitious
• Reliable
• Enduring

If our values resonate with you and you think you can contribute, we would be delighted to hear from you!

Don't meet every single requirement? At BW, we value diversity and the unique experiences that people from different backgrounds bring to our business. We welcome you to apply for the role even if you don't fully meet all the listed requirements, especially if you are passionate about building an inclusive culture where we strive to be our best. You may be just the right candidate!

Information for Recruitment Agencies:

BW endeavours to recruit and fill vacancies directly. However, when we do need to engage with agencies, BW operates a preferred supplier list (PSL) and will not be accepting unsolicited applications from non-PSL agencies for this role.

Job Description & Responsibilities

• Maintenance of Quality Management System ensuring compliance to internal, and international standards and regulatory requirements for medical devices.
• Develop QMS documents in line with business activity of DxD Hub.
• Ensure the overall document control system supports the QMS.
• Work with technical team to create quality document related to product design, development, and manufacturing, including product test/validation protocols, change management in compliance to applicable regulatory requirements.
• Lead auditor for internal and external audits.
• Conduct management review, ensure QMS stays current and relevant.
• Lead in root cause analysis and CAPA.
• Analyze trends inquality performance.
• Drive improvement in the quality management system.

Job Qualifications

• At least a Bachelor’s degree in Science/Engineering or relevant related field.
• Possess at least 4 years of working experience in quality assurance in medical devices; thorough working knowledge of ISO 13485:2016.
• Good working knowledge in managing QMS in a medical device environment in compliance to ISO 13485:2016.
• Competent in quality assurance methodologies.
• Working knowledge in QA processes for design, development, and manufacturing of IVD, SaMD and Integrated Medical Technologies.
• Demonstrated skills in risk management (ISO 14971).
• Knowledge in regulatory requirements for medical devices in ASEAN, USA and EU.
• Strong background in biomedical, computer or engineering sciences.
• Awareness of applicable workplace environment, health, and safety regulations.
• Possess creative skills and problem-solving skills.
• Adeptness in cultivating professional networks and build strategic partnerships.
• Good communication skills.
• Demonstrates strong leadership capabilities and an agile mindset.

The above eligibility criteria are not exhaustive. A*STAR may include additional selection criteria based on its prevailing recruitment policies. These policies may be amended from time to time without notice. We regret that only shortlisted candidates will be notified.

Job Description & Responsibilities

• Maintenance of Quality Management System ensuring compliance to internal, and international standards and regulatory requirements for medical devices.
• Develop QMS documents in line with business activity of DxD Hub.
• Ensure the overall document control system supports the QMS.
• Work with technical team to create quality document related to product design, development, and manufacturing, including product test/validation protocols, change management in compliance to applicable regulatory requirements.
• Lead auditor for internal and external audits.
• Conduct management review, ensure QMS stays current and relevant.
• Lead in root cause analysis and CAPA.
• Analyze trends inquality performance.
• Drive improvement in the quality management system.

Job Qualifications

• At least a Master's degree in Science/Engineering or relevant related field.
• Possess at least 4 years of working experience in quality assurance in medical devices; thorough working knowledge of ISO 13485:2016.
• Good working knowledge in managing QMS in a medical device environment in compliance to ISO 13485:2016.
• Competent in quality assurance methodologies.
• Working knowledge in QA processes for design, development, and manufacturing of IVD, SaMD and Integrated Medical Technologies.
• Demonstrated skills in risk management (ISO 14971).
• Knowledge in regulatory requirements for medical devices in ASEAN, USA and EU.
• Strong background in biomedical, computer or engineering sciences.
• Awareness of applicable workplace environment, health, and safety regulations.
• Possess creative skills and problem-solving skills.
• Adeptness in cultivating professional networks and build strategic partnerships.
• Good communication skills.
• Demonstrates strong leadership capabilities and an agile mindset.

The above eligibility criteria are not exhaustive. A*STAR may include additional selection criteria based on its prevailing recruitment policies. These policies may be amended from time to time without notice. We regret that only shortlisted candidates will be notified.

Responsibilities:

• Lead and execute comprehensive audits for both listed companies and SMEs, locally and internationally, from planning through to completion, consistently meeting deadlines while demonstrating reliability and strong organizational skills as a key team member.
• Develop and apply effective problem-solving skills, providing actionable recommendations to management based on thorough industry research, insightful analysis, and investigative findings.
• Show initiative and uphold a strong work ethic, coaching junior staff, sharing knowledge, and understanding how individual contributions impact team performance and outcomes.
• Understand the role of the business unit within the broader firm context, actively building internal networks, and making meaningful contributions during client meetings alongside senior team members.

Requirements:

• Min Degree or professional accounting qualifications recognised by ISCA
• Minimum 2 years’ relevant experience with large/mid-tier international accounting firms
• Proactive, committed and able to work under pressure
• Possess initiative and the ability to work independently
• Team player

If you are interested, kindly apply through mycareersfuture.

I regret to share that only shortlisted candidates will be notified.

www.dadaconsultants.com

EA Registration Number: R21100604

Data provided is for recruitment purposes only

Business Registration Number: 201735941W.

Licence Number: 18S9037

Job Summary:

We are seeking a detail-oriented Compliance Manager to lead our compliance initiatives and ensure adherence to regulatory requirements. The ideal candidate will have a strong understanding of industry standards and regulations, excellent analytical skills, and the ability to communicate effectively across all levels of the organization.

Key Responsibilities:

• Develop, implement, and manage compliance programs to ensure adherence to local, state, and federal regulations.
• Conduct regular audits and assessments to identify compliance risks and areas for improvement.
• Monitor regulatory changes and update company policies and procedures accordingly.
• Provide training and support to employees on compliance-related issues and best practices.
• Collaborate with various departments to promote a culture of compliance throughout the organization.
• Prepare and present compliance reports to senior management and regulatory authorities as required.
• Act as a point of contact for regulatory bodies and manage all compliance-related inquiries.
• Investigate compliance breaches and develop action plans to address any issues identified.
• Maintain comprehensive documentation of compliance activities and programs.

Qualifications:

• Bachelor’s degree in Business Administration, Finance, Law, or a related field; advanced degree or certification.

Job description:

1. To plan, organize and monitor all activities relating to quality assurance to maintain quality standards and systems to meet customer requirements.

2. To define and control the characteristics of each part, affiliated with appropriate Inspection Plans; and make available the required facilities to verify these characteristics.

3. To oversee and approve First Article inspection procedures prior to sample submission to customers.

4. To issue material certificate to meet customer requirements.

5. To liaise with customers on matters related to quality.

6. To conduct/co-ordinate Material Review procedures to implement any Corrective/Preventive Action; and follow-up for a closure with result of satisfactory action taken.

7. To approve disposal of non-conforming items.

8. To ensure all inspections are conducted correctly.

9. To control and manage the Equipment Calibration System; setting the frequency of each calibration.

10. To report quality performance and critical discrepancy issues to General Manager.

11. To propose to General Manager an indicative rate of annual salary-increment and annual bonus of his subordinates reflected through the past year performance.

12. To approve the application of various type of Leave of his subordinates.

13. To approve petty-cash paid to his subordinates.

14. To recruit and upgrade his subordinates with relevant training programs and sue practical experiences.

15. To train subordinates in Sampling and Inspection techniques.

Experience Required:

At least 5 years experience in a Quality Control Management.

Skills required

1. Well-versed in ISO 9001:2000 requirement.

2. Quality Control System.

Qualification required

1. Mechanical/Manufacturing/Engineering Degree.

IT Exposure

1. Computer literate in MS Office.

2. Application knowledge in Autocad.

JOB DESCRIPTION:

• Responsible for day-to-day business data management and regular business report preparations, which includes SAP material master maintenance, data integrity checking and statistics.
• Daily monitoring of basic system health and to flag out any inconsistency in API/System functions when found/reported.
• Daily monitoring of system backend jobs and ensure transactional data are interfacing in healthy state with external/internal system.
• To support Business Analytics, extracting and reorganizing original data, dealing with data related issues with other departments.
• Responsible for data preparation, data mining, to create/identify opportunities through analytics, to optimize business objectives.
• Communicate findings and insights to relevant stakeholders in order to assist Manager in making data-driven decisions in KPI assessments.
• Drive continuous improvements /optimization of campaign performance tracking report with business while complying to A*STAR policies.

REQUIREMENTS:

• Bachelor's Degree preferably Business Analytics, Information systems or Computer Science.
• Strong analytical skills, with experience solving problems using data and providing practical business insights.
• Self-Starter with a strong sense of urgency.
• Aptitude to challenge the status quo, think outside the box, and question what has been done.
• Comfortable with dealing with sets of data points from different sources.
• Qualities of matured thinking, dependable and requires minimum supervision.
• Excellent communication skills (oral and written).

The above eligibility criteria are not exhaustive. A*STAR may include additional selection criteria based on its prevailing recruitment policies. These policies may be amended from time to time without notice. We regret that only shortlisted candidates will be notified.

Roles & Responsibilities

Cellvec Pte Ltd is currently looking for an experienced & Passionate QA professional who can fully support our clinical and commercial GMP manufacturing of Cell & Gene Therapy Products.

This role will provide you the opportunity to lead key activities to progress your career, these responsibilities include some of the following:

• Lead a team of QA professionals to manage and oversee all the areas of GMP operations. Always ensure inspection readiness.
• Effectively manage Change controls, Deviations, OOS, QRM, Document management, Trainings, Audits, Batch release, Qualifications & Validations, Business support, Trends & Reports, Annual Product quality review etc
• Supports regulatory and client audits as Quality subject matter expert.
• Provide QA expertise for cGMP documents including, but not limited to, SOPs, batch records, media fill/APS protocols and reports, validations, Qualifications, Environmental monitoring, Risk assessment and specifications.
• Strategize, plan and organise the team's resources to perform operations.
• Plan and develop working knowledge and stakeholder management of the team of Quality professionals.
• Promote the Quality culture on Site through exemplary behaviours.
• Ensures the implementation of adequate training for aseptic gowning, aseptic qualification, practices and QA observations.
• Participates in review of policies and policymaking.
• Ability to communicate quality operations and compliance perspective effectively to senior management.
• Understands and articulates company business strategy. Maintains a broad view of the business recognizes changes and trends in the appropriate area in which the individual operates.
• Responsibility to drive the focus on safety to the QA staff and into functional areas that routinely support CT/GT manufacturing.
• Any other tasks as and when assigned by the Supervisor.

Ideally, we are looking for candidates with these criteria’s:

• Minimum of Degree in Biochemistry/Microbiology/Biotechnology discipline. Master degree and above are preferred.
• A minimum of 10 years’ experience in the pharmaceutical/Biotech industry, preferably in CGT manufacturing and its GMP compliance.
• Demonstrated experience with helping operations to prepare for Regulatory GMP inspection. Experience managing HSA, USFDA, EU & Client audits are preferred.
• Experience in leading internal, External and regulatory audits. Experience formulating the audit responses and CAPA
• In-depth understanding of cGMP regulations and regulatory requirements of Biotech/Cell and gene industry.
• Strong experience, Extensive knowledge and hands-on experiences of handling Sterile pharmaceutical/Biotech manufacturing processes.
• Ability to apply optimal quality assurance standards to promote a business edge.
• Ability to facilitate business activities compatible to international regulatory environment.
• Ability to communicate effectively within the site organization and across the network.
• Good people management skills.
• Good risk management skills.
• Good Analytical thinking skills.
• Hands on experience in Working with Aseptic environments.
• Exposure in handling Quality Management Systems.
• Exposure in ensuring GLP compliance in QC Laboratory.

JOB DESCRIPTION:

• Responsible for day-to-day business data management and regular business report preparations, which includes SAP material master maintenance, data integrity checking and statistics.
• Daily monitoring of basic system health and to flag out any inconsistency in API/System functions when found/reported.
• Daily monitoring of system backend jobs and ensure transactional data are interfacing in healthy state with external/internal system.
• To support Business Analytics, extracting and reorganizing original data, dealing with data related issues with other departments.
• Responsible for data preparation, data mining, to create/identify opportunities through analytics, to optimize business objectives.
• Communicate findings and insights to relevant stakeholders in order to assist Manager in making data-driven decisions in KPI assessments.
• Drive continuous improvements /optimization of campaign performance tracking report with business while complying to A*STAR policies.

REQUIREMENTS:

• Bachelor's Degree or Diploma (with at least 5 years or more relevant experience), preferably Business Analytics, Information systems or Computer Science.
• Strong analytical skills, with experience solving problems using data and providing practical business insights.
• Self-Starter with a strong sense of urgency.
• Aptitude to challenge the status quo, think outside the box, and question what has been done.
• Comfortable with dealing with sets of data points from different sources.
• Qualities of matured thinking, dependable and requires minimum supervision.
• Excellent communication skills (oral and written).

The above eligibility criteria are not exhaustive. A*STAR may include additional selection criteria based on its prevailing recruitment policies. These policies may be amended from time to time without notice. We regret that only shortlisted candidates will be notified.

Assistant Manager / Manager, Quality Assurance

About CorDx:

CorDx is a multi-national biotech organization focused on pushing the limits of innovation and supply in global health. With over 2,000 employees across the world, serving millions of users in over 100 countries.

CorDx is transforming the global diagnostics industry with innovative R&D solutions, a vertically integrated supply chain, and manufacturing footprints in the United States and around the world.

With nearly two decades of IVD experience, CorDx is a leader in IVD research and development, manufacturing, and supply chain. Our proprietary line of rapid diagnostic products is recognized by families and medical professionals for reliability, affordability, and rapid results.

CorDx delivers rapid testing and point-of-care medical device solutions used in the detection of infectious disease such as COVID-19, pregnancy, drugs of abuse, biomarkers, and more. CorDx is at the cutting edge of technology, artificial intelligence, and data science with the goal of delivering diagnostic solutions to some of the most critical questions in healthcare.

Job Responsibilities

• Implement, manage and constantly improve the company’s quality management system, including but not limited to the IVD products and equipment;
• Regularly perform internal audits, compile audit reports, problem analysis reports, improvement proposals, and monitor the rectification plan and its implementation;
• Lead and Participate in the internal audits and management reviews of the company's quality system as key member of company's quality department;
• Manage the system and documents of company’s quality management system, including but not limited to the IVD products and equipment;
• Be specifically responsible for the IVD equipment quality management system;
• Statistical analysis of IVD equipment quality data, and draft reports and corrective and preventive measures;
• Update quality standards, laws and regulations and publish company quality policy;
• Establish collaborative and cooperative working relationship with key opinion leaders and the regulatory bodies;
• Collaborate with cross-functional teams to meet projects goals with overall organizational objectives.
• Any other ad-hoc duties or projects as required by the management team.

Qualifications:

• Quality system related training and internal auditor training;
• Familiar with ISO9000 & ISO13485 quality management system and certification work, experience with successful case(s) will be preferred;
• Familiar with GMP and medical device industry standards and specifications;
• Strong quality management system knowledge and capabilities;
• A bachelor's degree with 7 years of relevant experience, a master's degree with 3 years of relevant experience, or a doctorate degree with at least 1 year of relevant experience. Others are welcome to apply.
• Familiar with in vitro diagnostic products such as lateral flow immunoassay, PCR, Immunoassay etc;
• Familiar with IVD product development and commercialization life cycle;
• Systematical project management, good planning, execution and timely communication. Good presentation skills.
• Majoring in biology, medicine, laboratory science, immunology, pharmacy or quality engineering are preferred;
• Enthusiastic, proactive, and down-to-earth work attitude, strong communication & execution ability, results driven, and a team player;
• Meticulous and strong sense of responsibility; able to handle stress and tight schedule;

How to Apply:

• Please send a comprehensive resume, a cover letter (if applicable), along with your current and expected salary to foongying@cordx.com or click to submit here @ My careerfuture.
• We regret that only shortlisted candidates will be contacted

Responsibilities:

• To ensure supply chain processes comply with national regulatory compliance and meet international benchmarks and standards.
• Leads in addressing quality assurance issues in the production department
• Conduct walk by inspections and give real time feedback to team leaders and operators.
• Conduct regular internal audits, surveillance and inspections.
• Complete internal audits on time
• Update Quality manual
• Develop QA plans by conducting hazard analysis, identify Critical Control Points, implement preventive measures, establishing critical limits, monitor procedures, corrective actions and verification procedures.
• Provide advices on and propose in-house quality procedures, standards, and specifications to management.
• To assure consistency in product safety and quality by developing and enforcing Good Manufacturing Practice, validating existing processes, providing documentation and staff management.
• To work closely with Sales, Marketing, and Customer Service Departments to analyse customer complaints and feedbacks, and act as a catalyst for change and improvement in product quality to meet changes in existing customer’s requirements.
• Ensure ISO standards are implemented by all QC Executives (Food Technologist), team leaders and operators.
• To provide leadership and guidance, orientate, train, and guide QC / QA staff and other subordinates on their job.
• Work with Production and QC to establish SOP / WI for use in training staff, like new workers

Requirements:

• At least 3 years and above experience in a similar role in a food production company
• Mastery of FSSC 22000, ISO, HACCP, and Halal standards
• Experience in Food Safety regulatory auditing will be an added advantage
• Self-driven, self-discipline, good team worker
• Self-management (stress management, work organization, time management)
• Willingness and flexibility to work in special projects requiring his/her skills
• Able to communicate fluently in Mandarin and written Chinese

JOB DESCRIPTION:

• Responsible for day-to-day business data management and regular business report preparations, which includes SAP material master maintenance, data integrity checking and statistics.
• Daily monitoring of basic system health and to flag out any inconsistency in API/System functions when found/reported.
• Daily monitoring of system backend jobs and ensure transactional data are interfacing in healthy state with external/internal system.
• To support Business Analytics, extracting and reorganizing original data, dealing with data related issues with other departments.
• Responsible for data preparation, data mining, to create/identify opportunities through analytics, to optimize business objectives.
• Communicate findings and insights to relevant stakeholders in order to assist Manager in making data-driven decisions in KPI assessments.
• Drive continuous improvements /optimization of campaign performance tracking report with business while complying to A*STAR policies.

REQUIREMENTS:

• Bachelor's Degree or Diploma (with at least 5 years or more relevant experience), preferably Business Analytics, Information systems or Computer Science.
• Strong analytical skills, with experience solving problems using data and providing practical business insights.
• Self-Starter with a strong sense of urgency.
• Aptitude to challenge the status quo, think outside the box, and question what has been done.
• Comfortable with dealing with sets of data points from different sources.
• Qualities of matured thinking, dependable and requires minimum supervision.
• Excellent communication skills (oral and written).

The above eligibility criteria are not exhaustive. A*STAR may include additional selection criteria based on its prevailing recruitment policies. These policies may be amended from time to time without notice. We regret that only shortlisted candidates will be notified.

Careers that Change Lives

We are a learning culture. An inventive and collaborative group. We are dedicated to making sure that every patient gets the best product — when they need it. We have strong ties to our local communities. Our vibrant employee communities respect and value individual experience and perspective as we aim to improve lives and the access to healthcare.

A Day in the Life

• Leads the QA function to ensure quality system development and compliance with FDA's Quality System Regulation, 13485, MDD / EU MDR, and other quality requirements.
• Provides oversight for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines.
• Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.
• Provides guidance and coaching to all direct reports, includes establishing individual performance & development objectives and plan
• Leads the strategic planning the functional team in driving continual improvement and effectiveness of Quality Operations and Quality Systems.
• Establishes quality programs and initiatives to ensure products and assemblies are developed and manufactured in accord with applicable requirements.
• Leads and/or supports initiatives at Medtronic Singapore and across sites to ensure effective quality reporting, quality systems and quality improvement efforts and Customer-Focused Quality; supervise the Quality System implementation. Supports the implementation of engineering projects, including design transfers and provide management oversight in establishing the quality system requirement at other facilities and Medtronic projects.
• Act as the CAPA board chair to ensure effective CAPA process and drive the development of systems and processes for the identification, analysis, correction, and prevention of quality issues.
• Leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits.
• Works with Singapore and platform leadership team members in developing long and short-term business goals and strategies.
• Represents Singapore on OU/ enterprise Quality Leaders team meeting, collaborate with peers across all sites and Operating Units for global quality initiatives and works closely with peers on similar quality concerns between MDT sites.

Qualifications

Must Have

• Requires a Bachelor’s degree minimum of 5 years relevant experience, or advanced degree with a minimum of 3 years prior relevant experience.

Your Profile

• Minimum of 5 to 7 years management expertise in the Pharmaceutical, Medical Devices or any highly regulated manufacturing industry.
• Overall operational and financial acumen, Business and Project Management skills and experience a plus.
• Familiar with Quality System requirement and knowledge of Quality System Regulations and ISO.
• Broad management knowledge to lead a team and have a prior experience in manufacturing environment and Quality function.

About Medtronic

Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.

We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.

Physical Job Requirements

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.

JJIM aims to cultivate industry-leading capabilities that enhances competitiveness, aligned with HCP needs, and ultimately deliver improved outcomes for patients.

Under this umbrella, the CX& CD CoE aims JJIM to be the preferred partner for HCPs. The vision of this CoE is to deliver industry-leading, data-driven engagement with HCPs that is personalised, orchestrated and seamless across channels. Integrating Content Strategy and Operations closely with Content Approvals is a key enabler. This synergy between content and compliance ensures omnichannel content delivery with the highest quality and speed without compromising risk.

Tasked with the role of improving our content compliance approval workflow, this position will have a significant opportunity to directly drive enterprise growth and efficiency.

*Please note that the role will require 20% travel due to the regional portfolio.*

Key Responsibilities

The Content Compliance Manager will be responsible for supporting the optimized workflow and general management of the copy approval process for advertising and promotional materials and implementing modern practices of approval for content such as claims, components and modular content.

1. Copy Approval Process and Approval Framework:

Enables, advises, and implements risk framework for review and approval of ad/promo materials, claims, components, and modular content in APAC markets. Should be able to significantly reduce time of approval without compromising on risks.

2. Process Implementation:

Ensures optimized workflow is followed in markets with clear adoption plan. Ongoing partnership and communication with Compliant Communications Managers and cross-functional stakeholders (Regulatory, Medical, Legal, HCC, Data Privacy, ITS, Communications, Marketing) in order to achieve business objectives.

3. Technology / system expertise:

Will be expert on copy approval workflow and digital asset management system, provides guidance and support to the current team. Pro-actively collaborate with the business technology team to identify and implement technology optimization for reference, end to end workflow.

4. Cross functional squad delivery teams:

Building, leading and being part of cross-functional teams to deliver on content transformation initiatives. Support the adoption of key initiatives for cross-functional brand teams in the organization.

5. Collaborated with stakeholders beyond APAC:

Collaborate with global and cross-regional teams within JJIM to ensure best practices are identified and transferred to APAC.

Qualifications

At Johnson & Johnson, we value diverse experience, and we look for potential in candidates to move beyond the position they’re hired for. Below is a list of the top 4-5 skills and competencies that are important for this position, which candidates can either bring to this role, or where candidates may be able to learn and grow whilst in the role (this will be dependent on position).

Skills & Competencies

· Content Approvals & Change Management: Ability to lead large scale transformational change in Content approvals.

· Influencing & Stakeholder Management: Ability to influence, drive decisions and outcomes across multiple levels of the organisation, especially with HCC. Ability to work cross-functional teams.

· Strategic thinking and ability to translate strategy into actionable plans: Ability to distill insights into clear strategies aligned to our Vision, translate these into actionable plans (RACI) that drive business outcomes.

· Communication Skills: Excellent verbal, written, visual and facilitation communication skills.

Experience or qualifications that are critical to this position.

· Pharmaceutical experience. Medical, Regulatory or Legal experience, especially in content approvals

· Experience leading workflow optimization

· Understanding of new content practices such as modular content

· Understanding content, and content approvals workflows

· Understanding of approval systems in Veeva promo mats.

· Experience working in an Agile environment (desirable)

Job Summary :

We are looking for a Test Program Manager :

Requirements:

• 20 years of experiences in Banking Domain
• Experiences in Test Program Management Skills
• Experience in Investment Banking, Wealth Management Domain
• Experience in Temenos T24 Implementation Testing
• Excellent Communication and Stakeholder Management Skills

Qualification:

• Degree in related Discipline

JOB DESCRIPTION:

• Responsible for day-to-day business data management and regular business report preparations, which includes SAP material master maintenance, data integrity checking and statistics.
• Daily monitoring of basic system health and to flag out any inconsistency in API/System functions when found/reported.
• Daily monitoring of system backend jobs and ensure transactional data are interfacing in healthy state with external/internal system.
• To support Business Analytics, extracting and reorganizing original data, dealing with data related issues with other departments.
• Responsible for data preparation, data mining, to create/identify opportunities through analytics, to optimize business objectives.
• Communicate findings and insights to relevant stakeholders in order to assist Manager in making data-driven decisions in KPI assessments.
• Drive continuous improvements /optimization of campaign performance tracking report with business while complying to A*STAR policies.

REQUIREMENTS:

• Bachelor's Degree or Diploma (with at least 5 years or more relevant experience), preferably Business Analytics, Information systems or Computer Science.
• Strong analytical skills, with experience solving problems using data and providing practical business insights.
• Self-Starter with a strong sense of urgency.
• Aptitude to challenge the status quo, think outside the box, and question what has been done.
• Comfortable with dealing with sets of data points from different sources.
• Qualities of matured thinking, dependable and requires minimum supervision.
• Excellent communication skills (oral and written).

The above eligibility criteria are not exhaustive. A*STAR may include additional selection criteria based on its prevailing recruitment policies. These policies may be amended from time to time without notice. We regret that only shortlisted candidates will be notified.

Quality and Supply Chain Manager

Job Description

Nuevocor is a pre-clinical stage biopharmaceutical company dedicated to developing genetic medicines to treat the underlying cause of genetic cardiomyopathies. Backed by an international syndicate of reputable venture capital firms, it will focus on advancing its pipeline of programs to clinical trials. It will also leverage its platform technology, underpinned by a deep understanding of cardiac mechanobiology, to discover and develop therapies for multiple cardiomyopathies.

Nuevocor’s Singapore site is seeking to hire a Quality Manager to join our Tech Ops department to support advancing our therapeutic candidates forward. Reporting to the Head of Tech Ops, you will play a key role in setting up, managing and maintaining our Quality Management System and processes in compliance with relevant standards and regulatory requirements. You will be part of a dynamic and fast-paced biotech working environment.

Responsibilities

· Implement, manage and maintain a compliant GxP Quality Management System, encompassing the aspects of Quality Risk Management, CAPA, Deviations, Change Control, Quality Documentation.

· Conduct internal and external audits, including at sub-contractor facilities and processes.

· Provide on-site support at CDMOs for manufacturing production.

· Manage supply chain of materials across sites of CDMOs, CROs and clinical trial sites.

· Prepare Quality documentation and agreements.

· Review GxP protocols, reports and Standard Operating Procedures to ensure compliance.

· Develop and deploy the GxP quality assurance strategy as approved by senior management.

· Reports all critical and relevant quality and compliance issues to management.

· Ensures quality assurance expertise is available and effective for GxP operations.

· Provide Quality Assurance review and disposition of GxP products, as appropriate.

· Acting as a point of contact with regulatory authorities.

· Support the development and harmonization of quality standards and processes.

· Maintain good relationships with regulatory agencies.

· Ensure that all personnel training, investigations, actions, CAPAs are completed on time.

· Assists in the development and maintenance of training program.

· Lead and assist in the development of SOP and procedures to support GxP functions.

Requirements

· Scientific degree in Pharmaceutical Sciences or related fields.

· 5-10 years experience in GxP particularly GCP and GMP areas and other regulations applicable in the Pharmaceutical Industry.

· Experience with supply chain and shipping, preferably with biologics materials.

· Knowledge of drug development regulations and implementing GxP in Gene Therapies

· Actively able to manage multiple projects to meet timelines, while maintaining compliance.

· Ability to work in teams with diverse cultural and professional backgrounds

· High standards in documentation and record keeping.

· Strong interpersonal and organizational skills

· Strong collaboration and team working skills

· Excellent writing and verbal communication skills

· Excellent problem solving ability

· Ability to multitask

· Possess a mindset of no job too big or too small

Nuevocor is an equal opportunity and equal benefits employer. All qualified applicants will receive consideration for employment. Position is commensurate with experience.

Interested candidates, please submit a CV and cover letter to tinyurl.com/nuevocorcareer

This role will Ensure products manufactured by contract manufacturer meet all defined specifications and are developed and manufactured in compliance with all applicable quality system requirements and provide leadership to work with different Medtronic entities and set up the strong relationship to support the implementation of Quality Systems for the new entity in implementing China localization strategy.

Primary Responsibilities

• Set up the Quality Systems to it meets Singapore, China and requirement countries requirement.
• Establishes quality programs and initiatives to ensure products and assemblies are developed and manufactured per applicable requirements.
• Establish strong supplier control and Quality oversight over suppliers and Medtronic entities.
• Driving continual and preventive improvement of quality management systems in supporting the conformity of process and product quality.
• Supports and develops systems for the identification, analysis, correction, and prevention of quality issues.
• Contributes quality expertise to product development and manufacturing transfers including working closely with suppliers to implement robust manufacturing processes and Quality oversight.
• Oversees and lead key quality systems processes to ensure its effectiveness which includes Design Control, Supplier Controls, Quality Planning, Document Controls, Training, Audits, Change Controls, Nonconformance CAPA, Manage External Requirement, etc.
• Leads the site audit readiness and manages, conducts and coordinates external (Singapore, China, ISO, etc.) audits.
• Take preventive actions to improve the compliance and effectiveness of Quality Management Systems by proactive learning from other sites and best practices from the industry.
• Provides QA support, participate and collaborate with Operating Units improvement program
• Works with local management team members in developing long and short-term quality goals and strategies.
• CAPA board memberParticipate in CAPA and board meetings to review the trending of all input sources and determine if any further action is needed
  Perform review on the CAPA investigation, action plan and effectiveness to determine if CAPA process requirement are fulfilled.
• Represents the new entities to collaborate with peers across all Operating Units for global quality initiatives and works closely with peers on similar quality concerns between Medtronic sites

Qualifications - External

Must Haves

• Bachelors Degree required
• Minimum of 5 years of relevant experience, or advanced degree with a minimum of 3 years of relevant experience