品保部 QA Project Manager

Quality Assurance Project Management (QA PM), is responsible for leading and coordinating quality-related projects across the end-to-end GMP lifecycle. This role ensures that all quality activities, deliverables, and documentation are executed in compliance with regulatory requirements and internal quality systems. The ideal candidate possesses strong GMP expertise and excels in cross-functional communication, particularly when managing interactions with external partners such as CDMOs, contract testing laboratories, and suppliers.

Project Management:

• Lead and manage QA-related projects, including system implementation,

remediation activities, audits, and process improvements.

• Develop project plans, timelines, milestones, risk assessments, and resource

requirements.

• Track project progress, escalate critical risks, and ensure timely completion of

deliverables.

• Facilitate cross-functional project meetings and maintain project

documentation.

Quality System Oversight:

• Support maintenance of quality systems, including Document Management,

Change Control, Deviation/OOS, CAPA, Training, Supplier Management, and
Data Integrity programs.

CMO/CTO and Vendor Management:

• Serve as QA project liaison for external manufacturing sites, laboratories, and

suppliers.

• Coordinate quality agreements, quality metrics, deviation/OOS escalations, and

batch release documentation.

• Monitor vendor performance and support periodic reviews.

Batch Release & Product Quality:

• Oversee the GMP documents required for lot disposition, including batch

records, testing results, deviations, and investigation reports.

• Ensure timely communication of batch status and quality issues to internal

stakeholders.