DMAH质量负责人

Reporting to the SOQ China Team Lead, this role ensures compliance with global and local regulatory requirements, including GMP, GSP, MAH Domestic Responsible Entity (DMAH) regulation and Pfizer Quality Standards. This role provides both strategic leadership and hands-on oversight across end-to-end quality operations, ensuring robust product quality, regulatory compliance, and supply continuity within the Chinese market.
In this role, leading the SOQ team and partnering with global and local stakeholders including Regulatory Sciences, Global Supply Chain (GSC), Medical, Commercial, External Supply Operations Quality, and PGS to drive quality excellence and regulatory compliance.
This role is act as DMAH quality responsible person registered in SH FDA
● Act as a designated quality leader of oversea Marketing Authorization Holder Domestic Responsible Entity (DMAH) responsible for ensuring quality oversight of imported products within the market
● Ensure compliance with GMP, GDP/GSP, and all applicable regulatory requirements for the market.
● Lead the implementation and continuous improvement of the Quality Management System (QMS), aligned with global standards.
● Oversee and ensure compliant distribution, storage and market release of all products in alignment with local regulatory requirements, enabling timely and uninterrupted market supply.
● Drive the development and execution of quality systems that enhance compliance, mitigate risk, and improve performance.
● Lead quality-related projects, ensuring alignment with global objectives and effective use of resources.
● Monitor and assess quality KPIs to identify trends, escalate issues, and drive corrective and preventive actions.
● Lead audit and inspection readiness, including coordination of Product Quality and GDP/GSP/DMAH/MAH inspections at PCOs.
● Establish and maintain robust quality systems at PCOs, including complaint management, deviations, market actions, product evaluation and release, and local relabelling/repackaging.
● Lead Quality Review Team (QRT) meetings and coordinate market actions and regulatory communications.
● Partner with regional and country leadership to ensure appropriate resourcing and sustained compliance of quality systems.
● Provide regular, clear updates to management on PCO quality performance and improvement initiatives.
● Foster a strong culture of quality, compliance, accountability, and continuous improvement across region.
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● Build and lead a high-performing quality team, providing clear guidance, training, and support to enable effective execution of responsibilities.
● Drive team engagement, clear vision, effective communication, and development of direct reports by being available and present.
● Facilitate the development and execution of objectives/projects consistent with SOQ Purpose Blueprint.
● Build a culture of continuous improvement, ownership, and proactive problem-solving.
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● Partner with GSC, Global Regulatory Sciences, commercial, Legal, PGs Sites and any 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.
● Ensure the compliant management and maintenance of suppliers using the lifecycle management approach for supplier/Sales Intermediary quality management.
● Ensures a process is in places for supplier/Sales Intermediary qualification, where required.
● Oversees quality operations at GxP suppliers/Sales Intermediary and agree on any action plans to ensure compliance and continuous improvement.
● Coordinate RQA audits at the supplier/Sales Intermediary.
● Technical support as needed for IDC importation testing / surveillance testing
● Work with PGS Site/GRS on annual product report for regulation requirements
● Lead annual product report preparation and ensure APR and APQRs submission complies with regulation requirements
● Other requirements from local regulations
Level of Education
Bachelor’s degree in pharmacy, Biology, Chemistry, or related scientific discipline.
Experience
● Minimum 7 years of relevant experience in pharmaceutical quality roles, including experience in Supply Operation Quality, with a thorough understanding of quality systems and drug GMP, GDP/GSP, DMAH, medical device GDP compliance requirements.
● Proven ability to influence and collaborate across functions .
● Licensed Pharmacist
● Experience engaging with local health authorities and managing regulatory inspections.
● Skilled in technical writing, reporting, and quality documentation.
● Demonstrated leadership in matrixed, multicultural environments.
● Must be fluent in English and Chinese (written & verbal)
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