Supply Operation Quality- Senior Manager

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.

Responsibilities

Act as the designated quality leader of the Overseas Marketing Authorization Holder Domestic Responsible Entity (DMAH); Serve as the primary liaison with NMPA, SH FDA, and other local health authorities on quality-related matters; Ensure compliance with GMP, GDP/GSP, DMAH regulations; Lead implementation and continuous improvement of the Quality Management System (QMS); Oversee and ensure compliant distribution, storage, labelling, packaging, and market release of imported products; Manage quality oversight of third-party logistics, contract laboratories, and local relabelling/repackaging operations; Support pharmacovigilance activities; Monitor and analyse Quality KPIs; Lead audit and inspection readiness activities; Lead Quality Review Team (QRT) meetings; Establish quality systems including complaint management, deviations (SIR), CAPAs, change controls, market actions, and product evaluation and release; Lead regional and global quality initiatives and strategic projects; Lead annual product report preparation and APR/APQR submissions; Ensure compliant management of suppliers and Sales Intermediaries; Partner with GSC, Global Regulatory Sciences, Medical, Commercial, Legal, PGS Sites; Build and lead a high-performing SOQ team; Review and approve critical quality documents; Deliver quality reports to senior leadership

Requirements

Bachelor’s or master’s degree in pharmacy, biology, chemistry, or a related scientific discipline; Minimum 7 years of relevant experience in pharmaceutical quality roles, including Supply Operations Quality, with a thorough understanding of quality systems and GMP, GDP/GSP, DMAH, and medical device GDP compliance requirements; Licensed Pharmacist (required for DMAH Quality Responsible Person registration with SH FDA); Proven ability to influence and collaborate across functions in a matrix organisation; Strong technical expertise in DMAH and GSP regulations, ensuring compliance with local and global quality requirements; Proven capability to lead and execute QMS activities, including deviations (SIR), investigations, CAPA, change control, complaints, and document control; Extensive experience in inspection readiness and audit management, including hosting SH FDA inspections, responding to observations, and ensuring timely closure of commitments; Experience engaging with local health authorities (NMPA/SHFDA) and managing regulatory inspections; Strong capability in supplier and vendor quality management, including qualification, performance monitoring, and oversight of vendor CAPAs and action items; Demonstrated leadership in matrixed, multicultural environments with proven experience leading and developing direct reports; Fluent in English and Chinese (both written and verbal); Skilled in technical writing, reporting, and quality documentation; Exceptional verbal and written communication skills, including the ability to deliver compelling presentations; Ability to manage complexity, prioritise effectively, and work cross-functionally.

Nice to have

A Master’s degree coupled with relevant pharmaceutical experience; Proven track record of managing multiple projects; Strong conflict resolution skills, demonstrating the ability to navigate and resolve disputes effectively; Experience with quality risk management initiatives; Knowledge of regulatory requirements and quality systems; Ability to drive innovation and implement new ideas; Ability to assess and develop talent within the organization; Experience in leading strategic initiatives and influencing senior management decisions; Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance productivity. Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices, including risk management and ethical use