Purpose: Ensure implementation and oversight of the GCP Quality Management System (QMS) for clinical development activities in China, aligned with global standards and regulatory requirements, while driving digital and AI-related initiatives.
Key Responsibilities
Quality Management & Compliance
- Implement GCP QMS strategy locally; maintain Level 1 GCP quality documents.
- Ensure consistency with regulatory expectations through planning, monitoring, and continuous improvement.
- Act as Subject Matter Expert (SME) and point-of-contact for clinical quality requirements, promoting Quality-by-Design principles.
Inspection & Audit Readiness
- Ensure inspection readiness and manage regulatory inspections with cross function.
- Serve as primary contact for audit response management as needed
Vendor Quality Oversight
- Develop and execute Vendor Quality Plans; monitor vendor compliance.
- Drive remediation strategies for vendor quality issues and ensure timely resolution.
Quality Culture & Training
- Promote GCP quality culture across teams and vendors.
- Conduct knowledge-sharing sessions and embed learnings into QMS systems for continuous improvement.
Digital & AI Innovation
- Actively contribute to digital and AI initiatives in China, including STRAT projects.
- Support AI-enabled Site Start-Up (SSU), participant recruitment, eSource, Care anywhere initiatives, and data analysis.
- Collaborate with global and local teams to implement AI-driven solutions for quality improvement and operational efficiency.
Collaboration
- Engage with internal and external experts to monitor trends and implement best practices.
Qualifications
Advanced scientific/technical degree preferred (MS/MD/PhD); business coursework desirable.
Experience:
- Minimum 5 years in Clinical Development Quality roles with increasing responsibility.
- Strong knowledge of GCP principles, clinical development process (Phases I–IV), and regulatory requirements.
Skills:
Project management, strategic planning, and complex decision-making.
Excellent communication and stakeholder engagement skills (local and global).
Digital & AI Competency:
- Solid understanding of AI concepts and applications in clinical development.
- Ability to lead or significantly contribute to AI-driven initiatives (SSU, recruitment, eSource, etc).
Work Location Assignment: On Premise
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Quality Assurance and Control