Pfizer
SupplyOperationQuality-SeniorManager
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“Supply Operation Quality- Senior Manager at Pfizer. Skills: Quality leadership, Regulatory compliance, Quality management, Supplier management. Lead the Quality function for the China Pfizer. Ensure full compliance with global and local regulations”
What You'll Achieve.
Ensure full compliance with global and local regulations; Ensure timely and uninterrupted market supply; Enhance compliance; Mitigate risk; Elevate performance; Deliver measurable outcomes; Ensure compliance and continuous improvement; Sustained compliance of quality systems
Industry & Context.
Proactive problem-solving; Escalate issues; Drive corrective actions; Drive preventive actions; Conflict resolution
What They're Looking For.
Must Have
Bachelor's or master's degree in pharmacy, biology, chemistry, or related scientific discipline, Minimum 7 years of relevant experience in pharmaceutical quality roles, 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, Technical expertise in DMAH and GSP regulations, Proven capability to lead and execute QMS activities, Extensive experience in inspection readiness and audit management, Experience engaging with local health authorities (NMPA/SHFDA), Capability in supplier and vendor quality management, Demonstrated leadership in matrixed, multicultural environments, 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, Ability to manage complexity, prioritise effectively, and work cross-functionally
Nice to Have
Master's degree coupled with relevant pharmaceutical experience, Proven track record of managing multiple projects, Conflict resolution skills, 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, Understanding of responsible AI practices, including risk management and ethical use
What You'll Do.
Lead the Quality function for the China Pfizer
Ensure full compliance with global and local regulations
Provide strategic direction and hands-on oversight of end-to-end
Oversee product testing
Act as the main Quality contact for the
Act as the designated DMAH Quality Responsible Person
Drive quality excellence across the China market
Ensure regulatory compliance with NMPA/SHFDA requirements
Champion continuous improvement across the China market
Support business development activities for the China market
Conduct quality due diligence for new product launches
Act as the primary liaison with local health
Ensure quality oversight of imported products within the
Serve as the primary liaison with NMPA
Ensure compliance with GMP
Lead the implementation and continuous improvement of the
Oversee and ensure compliant distribution
Enable timely and uninterrupted market supply
Manage quality oversight of third-party logistics
contract laboratories
Drive the development and execution of quality systems
Provide support for pharmacovigilance activities
Monitor and analyse Quality KPIs to identify trends
Lead audit and inspection readiness activities
Coordinate Product Quality
and DMAH/MAH inspections at
Lead Quality Review Team (QRT) meetings
Coordinate market actions and regulatory communications
Establish and maintain robust quality systems including complaint
Lead and drive regional and global quality initiatives
Align initiatives with global objectives and China market
Champion innovation and continuous improvement by identifying opportunities
Lead annual product report preparation
Ensure APR and APQR submissions comply with regulatory
Ensure compliant management and maintenance of suppliers and
Oversee qualification
performance monitoring
and quality operations at
Agree on action plans to ensure compliance and
Coordinate RQA audits at suppliers and Sales Intermediaries
Global Regulatory Sciences
Ensure uninterrupted product supply and regulatory alignment
Act as a quality advocate in cross-functional forums
Ensure quality considerations are embedded in decision-making
Build and lead a high-performing SOQ team
Provide clear guidance
and support to enable
Drive team engagement
communicate a clear vision
Ensure all personnel are trained and compliant with
Foster a culture of accountability
Review and approve critical quality documents including SOPs
data-driven quality reports to senior leadership
Provide regular updates on PCO quality performance and
Partner with regional and country leadership to ensure
How You'll Work.
Team & Collaboration
Cross-functional collaboration; Partner with key functions; Quality advocate in forums; Quality considerations in decisions; Lead SOQ team; Develop direct reports; Report to senior leadership; Partner with regional leadership
Communication Scope
Verbal communication; Written communication; Presentations; Reporting; Regulatory communications
Process & Methodology
Strategic projects, Project management
Full Job Description
**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
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