Act as the designated quality leader of the Overseas Marketing Authorization Holder Domestic Responsible Entity (DMAH), responsible for ensuring quality oversight of imported products within the Chinese market.
Serve as the primary liaison with NMPA, SH FDA, and other local health authorities on quality‑related matters, inspections, and product quality issues.
Ensure compliance with GMP, GDP/GSP, DMAH regulations, and all applicable regulatory requirements.
Lead the implementation and continuous improvement of the Quality Management System (QMS) in alignment with global standards.
Oversee and ensure compliant distribution, storage, labelling, packaging, and market release of imported products, enabling timely and uninterrupted market supply.
Manage quality oversight of third‑party logistics, contract laboratories, and local relabelling/repackaging operations.
Drive the development and execution of quality systems that enhance compliance, mitigate risk, and elevate performance.
Provide support for pharmacovigilance activities in alignment with the working mechanisms of the Drug Safety Committee for the DMAH entity.
Performance Monitoring & Risk Management
Monitor and analyse Quality KPIs to identify trends, escalate issues, and drive corrective and preventive actions.
Lead audit and inspection readiness activities, including preparation and coordination of Product Quality, GDP/GSP, and DMAH/MAH inspections at PCOs.
Lead Quality Review Team (QRT) meetings and coordinate market actions and regulatory communications.
Establish and maintain robust quality systems including complaint management, deviations (SIR), CAPAs, change controls, market actions, and product evaluation and release.
Initiative & Project Leadership
Lead and drive regional and global quality initiatives and strategic projects that align with global objectives and China market needs.
Champion innovation and continuous improvement by identifying opportunities, mobilising resources, and delivering measurable outcomes.
Lead annual product report preparation and ensure APR and APQR submissions comply with regulatory requirements.
Supplier & Sales Intermediary Quality Management
Ensure compliant management and maintenance of suppliers and Sales Intermediaries using a lifecycle management approach.
Oversee qualification, performance monitoring, and quality operations at GxP suppliers and Sales Intermediaries, agreeing on action plans to ensure compliance and continuous improvement.
Coordinate RQA audits at suppliers and Sales Intermediaries.
Cross-Functional Collaboration
Partner with GSC, Global Regulatory Sciences, Medical, Commercial, Legal, PGS Sites, and other key functions to ensure uninterrupted product supply and regulatory alignment.
Act as a quality advocate in cross‑functional forums, ensuring quality considerations are embedded in decision‑making.
Capability Building & Team Development
Build and lead a high‑performing SOQ team, providing clear guidance, training, andsupport to enable effective execution of responsibilities.
Drive team engagement, communicate a clear vision, and develop direct reports by being available and present.
Ensure all personnel are trained and compliant with relevant quality procedures and regulatory expectations.
Foster a culture of accountability, ownership, continuous learning, proactive problem‑solving, and operational excellence.
Governance & Reporting
Review and approve critical quality documents including SOPs, deviations, change controls, and product quality reviews.
Delive
Benefits
Health insuranceVision insurance
Additional Information
Position Summary
As the SOQ China Senior Manager, you will lead the Quality function for the China Pfizer Country Office (PCO), ensuring full compliance with global and local regulations, including GMP, GSP, DMAH (Domestic Marketing Authorization Holder) regulations, and Pfizer's quality standards. You will provide both strategic direction and hands-on oversight of end‑to‑end quality operations-covering product testing, release, distribution, supplier management, and pharmacovigilance support. You will be the main Quality contact for the China PCO and Above Market organisation, and act as the designated DMAH Quality Responsible Person registered with SH FDA.
Reporting to the SOQ APAC Region & Hub Senior Director, success in this role relies on strong cross‑functional collaboration with Regulatory Sciences, Global Supply Chain (GSC), Medical, Commercial, External Supply Operations Quality, and Pfizer Global Supply (PGS) sites. You will drive quality excellence, ensure regulatory compliance with NMPA/SHFDA requirements, and champion continuous improvement across the China market.
This role also supports business development activities for the China market, including quality due diligence for new product launches, market expansions, and partnership evaluations, while acting as the primary liaison with local health authorities on regulatory inspections and product quality issues.
Pfizer · China