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, e Source, 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, e Source, 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: