Clinical Quality Manager

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 IIV) 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).

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.