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 & ComplianceImplement 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 ReadinessEnsure inspection readiness and manage regulatory inspections with cross function.Serve as primary contact for audit response management as neededVendor Quality OversightDevelop and execute Vendor Quality Plans; monitor vendor compliance.Drive remediation strategies for vendor quality issues and ensure timely resolution.Quality Culture & TrainingPromote GCP quality culture across teams and vendors.Conduct knowledge-sharing sessions and embed learnings into QMS systems for continuous improvement.Digital & AI InnovationActively 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.CollaborationEngage 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