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
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Quality Management & Compliance
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Implement GCP QMS strategy locally; maintain Level 1 GCP quality documents.
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Ensure consistency with regulatory expectations through planning, monitoring, and continuous improvement.
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Act as Subject Matter Expert (SME) and point-of-contact for clinical quality requirements, promoting Quality-by-Design principles.
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Inspection & Audit Readiness
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Ensure inspection readiness and manage regulatory inspections with cross function.
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Serve as primary contact for audit response management as needed
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Vendor Quality Oversight
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Develop and execute Vendor Quality Plans; monitor vendor compliance.
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Drive remediation strategies for vendor quality issues and ensure timely resolution.
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Quality Culture & Training
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Promote GCP quality culture across teams and vendors.
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Conduct knowledge-sharing sessions and embed learnings into QMS systems for continuous improvement.
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Digital & AI Innovation
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Actively contribute to digital and AI initiatives in China, including STRAT projects.
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Support AI-enabled Site Start-Up (SSU), participant recruitment, eSource, Care anywhere initiatives, and data analysis.
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Collaborate with global and local teams to implement AI-driven solutions for quality improvement and operational efficiency.
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Collaboration
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Engage with internal and external experts to monitor trends and implement best practices.
Qualifications
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Advanced scientific/technical degree preferred (MS/MD/PhD); business coursework desirable.
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Experience:
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Minimum 5 years in Clinical Development Quality roles with increasing responsibility.
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Strong knowledge of GCP principles, clinical development process (Phases I–IV), and regulatory requirements.
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Skills:
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Project management, strategic planning, and complex decision-making.
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Excellent communication and stakeholder engagement skills (local and global).
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Digital & AI Competency:
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Solid understanding of AI concepts and applications in clinical development.
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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
