This role provides support to the Asia Pacific region on the Commercial Quality Excellence responsibilities. The role ensures that all the strategic global and regional commercial quality initiatives/projects are successfully rolled-out and progressed in the APAC region. The incumbent in this role also provides operational support to all the markets in the region by working with Director of Global Commercial Quality Assurance.
RESPONSIBILITIES:
· Carries out duties in compliance with established business policies and procedures.
· Demonstrates commitment to the development, implementation, and effectiveness of applicable Quality Processes as per ISO, and other regulatory agencies.
· Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices.
· Responsible for developing, implementing, and maintaining project management activities.
· Participate in strategic projects’ review meetings and manage the project governance in the region.
· Drive implementation of strategic initiatives required for the commercial quality team (annual goal creation and subsequent project rollout, field corrective action communication and rollout, etc.) for the APAC region.
· Manage broad and cross-functional quality projects related to the Commercial Quality.
· Responsible for working with each of the APAC markets to provide operational quality support in consultation with the Director of Global Commercial Quality.
· Support the Audit readiness programs in the APAC region and work closely with the affiliates to support the preparation of key audits and inspections((Corporate Quality Audits, Regulatory Audits, ISO-Notified Bodies)
· Responsible for supporting the APAC affiliates on the Quality and Regulatory requirements; ensuring compliance to Abbott Global Quality/Regulatory Framework, Divisional Policies/ Procedures.
· Responsible for proactively creating Quality Culture by training the Commercial teams.
· Engage as required for the Quality Complaints for Abbott products, ensuring timely investigation, resolution, closure & customer follow-ups through the Legal Manufacturers and Tech Support Team. Proactively reviewing product complaints and address the trends in a timely manner.
· Act as the point of contact/coordination in APAC with other global entities in fulfilling Field Corrective actions (FCA) resulted from Regulatory Field Safety Notifications.
· Supporting Supplier Management Program in the region (Identification, Evaluation through Audits, Monitoring, Maintenance & Re-Qualification).
· Supporting Budgetary Planning for Quality Operations, as needed.
· Support quality remediation programs.
· Continuously drive for compliance with Abbott quality standards and regulatory requirements.
· Other duties as assigned.
BASIC QUALIFICATIONS | EDUCATION:
- Bachelor’s Degree in Pharmacy/Science/Engineering.
- Minimum 3 years of relevant experience in Medical Device/Pharmaceutical /In-Vitro Diagnostics/Healthcare industry with experience in conducting and handling audits and inspections.
- Strong analytical, communication, decision-making and leadership skills for interaction with external and internal customers and partners.
- Strong ability to negotiate with stakeholders.
- Able to manage multiple priorities
- Superior attention to accuracy and details.
- Strong leadership skills, including the ability to set goals and provide constructive feedback respectfully in order to build positive relationships and improve business results.
- Capable of understanding and overcoming different cultural and language barriers to provide solutions that satisfy corporate, regional, and local objectives.
- Strong verbal and written communication skills with the ability to convey appropriate information with clarity and effectiveness.
- Strong knowledge of relevant medical device industry regulations for quality systems and compliance.
- Ability to work in a highly matrixed and geographically diverse business environment.
- Ability to work effectively within a team in a fast-paced changing environment. Multi-tasks, prioritizes and meets deadlines in timely manner.
