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.
Key Responsibilities
Quality Leadership & Compliance
- 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.
- Deliver clear, data‑driven quality reports to senior leadership and global quality stakeholders, including regular updates on PCO quality performance and improvement initiatives.
- Partner with regional and country leadership to ensure appropriate resourcing and sustained compliance of quality systems.
Qualifications
- 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.
Bonus Points If You Have (Preferred Requirements)
- 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
Work Location Assignment: Hybrid
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers.
Quality Assurance and Control
