Company
DMAH质量负责人
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“DMAH质量负责人. Skills: quality operations oversight, regulatory compliance, quality systems implementation. Ensure compliance with global and local regulatory requirements. Provide strategic leadership and hands-on oversight”
What You'll Achieve.
ensuring robust product quality; regulatory compliance; supply continuity; drive quality excellence; enhance compliance; mitigate risk; improve performance; ensure uninterrupted product supply; ensure regulatory alignment
Industry & Context.
proactive problem-solving
What They're Looking For.
Must Have
Minimum 7 years of relevant experience in pharmaceutical quality roles, experience in Supply Operation Quality, thorough understanding of quality systems, 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, managing regulatory inspections, Skilled in technical writing, reporting, quality documentation, Demonstrated leadership in matrixed, multicultural environments, fluent in English, Chinese (written & verbal)
What You'll Do.
Ensure compliance with global and local regulatory requirements
Provide strategic leadership and hands-on oversight
Ensure robust product quality
Ensure regulatory compliance
Ensure supply continuity
Partner with global and local stakeholders
Drive quality excellence
Act as DMAH quality responsible person
Ensure quality oversight of imported products
Ensure compliance with GMP
Lead QMS implementation and continuous improvement
Oversee and ensure compliant distribution
Oversee and ensure compliant storage
Oversee and ensure compliant market release
Enable timely and uninterrupted market supply
Drive development and execution of quality systems
Lead quality-related projects
Ensure alignment with global objectives
Ensure effective use of resources
Monitor and assess quality KPIs
Drive corrective and preventive actions
Lead audit and inspection readiness
Coordinate inspections at PCOs
Establish and maintain robust quality systems at PCOs
Coordinate market actions
Coordinate regulatory communications
Partner with regional and country leadership
Ensure appropriate resourcing
Ensure sustained compliance of quality systems
Provide regular updates to management
Foster a culture of quality
Foster a culture of compliance
Foster a culture of accountability
Foster a culture of continuous improvement
Build and lead a high-performing quality team
Provide clear guidance
Enable effective execution of responsibilities
Drive team engagement
Drive effective communication
Drive development of direct reports
Facilitate development and execution of objectives/projects
Build a culture of ownership
Build a culture of proactive problem-solving
Partner with Global Regulatory Sciences
Partner with commercial
Partner with PGs Sites
Ensure uninterrupted product supply
Ensure regulatory alignment
Act as a quality advocate
Ensure quality considerations are embedded in decision-making
Ensure compliant management and maintenance of suppliers
Ensure a process is in place for supplier qualification
Oversee quality operations at GxP suppliers/Sales Intermediary
Agree on action plans
Coordinate RQA audits at the supplier/Sales Intermediary
Provide technical support for IDC importation testing
Provide technical support for surveillance testing
Work with PGS Site/GRS on annual product report
Lead annual product report preparation
Ensure APR and APQRs submission complies with regulation requirements
Fulfill other requirements from local regulations
How You'll Work.
Team & Collaboration
Partnering with global and local stakeholders; Partner with regional and country leadership; Partner with GSC, Global Regulatory Sciences, commercial, Legal, PGs Sites; Act as a quality advocate in cross-functional forums
Communication Scope
Provide regular, clear updates to management; Drive effective communication
Process & Methodology
Lead quality-related projects, Facilitate the development and execution of objectives/projects
Full Job Description
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 relabell
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