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.
• 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.
• Ensure inspection readiness and manage regulatory inspections with cross function.
• Serve as primary contact for audit response management as needed
• Develop and execute Vendor Quality Plans; monitor vendor compliance.
• Drive remediation strategies for vendor quality issues and ensure timely resolution.
• Promote GCP quality culture across teams and vendors.
• Conduct knowledge-sharing sessions and embed learnings into QMS systems for continuous improvement.
• 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.
• 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).
• 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.
• 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).
• 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