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

Interested applicants are invited to apply directly at the NUS Career Portal.

Your application will be processed only if you apply via NUS Career Portal.

We regret that only shortlisted candidates will be notified.

Job Description

• The Research Assistant will work closely with the Principal Investigator on several research projects on using machine learning in chemical and control engineering problems
• The Research Assistant will help to develop machine learning models for both theory and applications in advanced control systems

Job Requirements

• A Bachelor degree in a relevant area, e.g., Chemical Engineering, Control Engineering, Computer Science, Chemistry, etc.
• Experienced in machine learning, optimization and programming languages (e.g., python, Matlab, C++, etc)
• Any experience with 1) advanced control, 2) machine learning theory and applications, and 3) chemical engineering and chemistry is a plus

Interested applicants are invited to apply directly at the NUS Career Portal.

Your application will be processed only if you apply via NUS Career Portal.

We regret that only shortlisted candidates will be notified.

Job Description

Sustainable Bio-platform for High Quality Microbial Protein Production. To perform experimental and simulation work on system integration sand life cycle assessment .

Job Requrements

Ph.D. degree in Chem. Eng. and related research areas.

Experience researcher in chemical, biomedical, and environmental engineering. System integration and LCA background will be desirable.

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

About Johnson & Johnson

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.

Johnson and Johnson Network Operations Team is seeking an innovative Manager - Network Performance Assurance!

Major Duties and Responsibilities :

This is a highly technical role that is part of a global team to troubleshoot and resolve sophisticated and chronic network performance/operational issues. The Performance Assurance Manager is a SME in all major network technologies such as Switching/Routing, WAN, WLAN, Firewalls, Load Balancers, Cloud Exchange/CoLo, Cloud-based network services, and SDN. This position will partner with peer technology domain teams (Desktop, Server, Application, Cloud, etc.) when vital to identify performance issues and drive the resolution. One of the primary goals of this position is to focus on improving global network reliability and resiliency by proactive remediation of potential issues that could cause future business impact. Additionally, this role will ensure that proactive corrective, and preventative activities resulting from Problem Management are implemented.

The Manager- Network Performance Assurance will be accountable for the assessment of network site health reports that focus on network performance, configuration review and identifying continuous improvement, single points of failure and any required remediation.

Additionally, the role will solicit and receive feedback from business partners regarding network performance with the goal of growing the reliability and stability of the global network. This role will also serve as internal consultant for operational projects, partner with the Global Network Engineering team to standardize configuration changes and automation based on findings and recommendations. The position will engage OEM’s for information regarding bugs, patches, software upgrades, and configuration changes.

Qualifications:

• Bachelor’s degree in STEM or Computer Networking or Data Communications ( Desired)
• Possess an advanced network certification such as CCNP / CCDP or higher (Desired)
• 10+ years of large / enterprise Network Operations expertise and experience (Required)
• 5+ Years of experience in Next Gen network technologies like Cloud Networking, SD-WAN and Network Virtualization (Desired)
• 3+ Years of experience in Itential, Ansible or Python, Automation / scripting (Desired)
• 3+ years of experience in tools integration and single plane of glass observability (Desired)

Knowledge, Skills and Abilities:

• Strong Network Troubleshooting & Operations experience in complex Network environments (Required)
• Solid understanding in these technologies: routing/switching, WAN technologies, EIRGP/BGP, VPN, SASE, Zero-trust, SDN (SDA, SDWAN), Cloud connectivity, Cloud-based Networking technology, WLAN Technologies (Required)
• Broad technical knowledge and experience with converged infrastructure, Switching/Routing in a large and complex network, DHCP, DNS, IP, IP management tools, network management applications, advanced WAN routing, WAN/LAN/Wireless LAN topologies, MPLS, EIGRP/BGP, Load Balancers, Firewalls etc. (Required)
• Knowledge of High availability / resiliency engineering (Required)
• Confirmed vendor management experience (Required)
• Solid experience using network management and troubleshooting tools include packet analysis (Required)
• Demonstrable experience leading virtual teams supporting a complex network environment
• Excellent written and oral communication skills (Required)
• Proven analytical, evaluative and problem-solving abilities; data-driven. (Required)
• Working knowledge on BI tools such as Power BI and Tableau. (Desired)
• Ability to optimally prioritize and execute in a fast paced environment (Required)
• Outstanding customer service orientation (Required)
• Extensive experience working in a team-oriented, collaborative environment (Required)
• Scripting in Itential, Ansible or Python, Automation / scripting, Virtual Networking (NSX), AWS, AZURE and Equinix Cloud Exchange ( Desired )

What’s in it for you…?

“Caring for the world, one person at a time…”

As an employee, we consider you as our most valuable asset. We take your career seriously. As part of a global team in an innovative environment, your development is key and our day-to-day responsibility. Through e-university, on job training, various projects, and programs, we ensure your personal growth. Our benefits make sure we care for you and your family now and in the future! We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love. As such, depending on location and subject to local legislation, candidates offered employment may be required to show proof of COVID-19 vaccination or, in certain countries, secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work. If you are invited to interview for the position, your recruiter will advise on the vaccine requirement status in your geographic location.

#JNJTech

Job Summary

• To promote an effective quality programme includes identifying, coordinating and participating with relevant departments on quality and patient safety training needs, standards development, design and implementation of audit tools and risk management activities:
• Monitor current healthcare trends in quality, patient safety metrics and performance improvement practices;
• Keep abreast of appropriate regulatory agency requirements related to quality assurance and patient safety standards;
• Responsible for service excellence programmes with a synergistic working relationship with clinical quality;
• To initiate continuous service improvements through constant monitoring / surveys, audits and training.

Job Responsibilities

1. Manage the incidences, customer feedback / complaints and provide timely responses and effective preventive measures;
2. Identify and implement service, clinical quality and patient safety improvements to close service gaps. Measure and evaluate data to determine the ultimate impact of the programs and initiatives;
3. Develop / Conduct training programmes to improve service standards and develop a culture of customer centric services;
4. Maintain statistics on Quality Indicators eg Productivity, Episodes & Unique Beneficiary data, Customer Service Survey Data (including incidents, feedback, compliments, complaints). Prepare documents for management reporting as required;
5. Assist to develop, implement and review policies and procedures relating to quality management functions for standardisation and compliance to quality standards;
6. Maintain an inventory of all policies and procedures within the organisation and ensure compliance to ISO 9001 standards;
7. Work with consultants and internal customers to achieve and maintain certification i.e. ISO 9001; Bizsafe, DPTM, etc.
8. Maintain external correspondences including MOH / AIC, ensure all correspondences are tracked.
9. Timely execution / submission of Service Excellence awards and external awards;
10. Any other tasks as assigned by the Manager / CEO.

Job Requirements

• Minimum Diploma in a relevant discipline, preferably Degree in any discipline
• Minimum 1 – 3 years experience in customer service, preferably in the Healthcare industry;
• Have a background in quality management and / or service excellence programmes;
• Data protection officer (DPO) experience is highly advantageous;
• Customer service training experience would be advantageous.
• Good communication (oral and written) skills;
• Resourceful and self-directed;
• Team player;
• Leadership qualities;
• Good PC skills especially Word, Excel and Powerpoint;
• Enjoy working and helping people at all levels;
• Ability to work in a fast-paced environment;
• Knowledge of statutory regulations and quidelines pertaining to all aspects of healthcare.

Interested applicants are invited to send in their detailed resumes, stating current and expected salary via APPLY NOW.

Only shortlisted candidates will be notified.