Clinical Quality Manager job opportunity at Pfizer.



DateMore Than 30 Days Ago bot
Pfizer Clinical Quality Manager
Experience: 5-years
Pattern: full-time
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loacation China - Shanghai - Shanghai, China
loacation China - Shangh..........China

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

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