QA Compliance Manager
Zuellig Pharma Taiwan
Pharmaceutical Manufacturing · 1,001-5,000 employees
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About the role
Lead the QA Compliance function to ensure adherence to pharmaceutical regulatory standards and manage the Quality Management System. Oversee critical investigations, risk assessments, and strategic client engagement while managing the QA team's performance.
What they look for
Requirements
Requires extensive experience in pharmaceutical quality compliance, including expertise in GMP/GDP and QMS management. Strong leadership skills are necessary to handle audits, regulatory inspections, and complex cross-functional projects.
Benefits
Full description
Zuellig Pharma is a leading healthcare solutions company in Asia, and our purpose is to make healthcare more accessible to the communities we serve. We provide world-class distribution, digital, and commercial services to support the growing healthcare needs in this region.
The company was started a hundred years ago and has grown to become a multibillion-dollar business covering 17 markets with over 12,000 employees. Our people serve more than 200,000 medical facilities and work with over 450 clients, including the top 20 pharmaceutical companies in the world.
Purpose of the Role:
- To lead the QA Compliance function, ensuring that all company processes adhere to strict pharmaceutical regulatory standards (GMP/GDP) and the internal Quality Management System (QMS). This senior leadership role is responsible for driving continuous improvement, managing quality-related risks, and leading the team in all critical compliance activities—including complex deviation investigations, change control, and strategic client engagement on quality matters.
What You’ll Do :
- Quality Management System (QMS)
Develop, optimize, and own the overall QMS to ensure robust compliance across operations.
Lead critical deviation investigations (acting as the Lead Quality Process Investigator — QPI) and drive the effective, timely completion of Corrective and Preventive Actions (CAPA).
Oversee and manage the end-to-end Change Control process, including comprehensive impact assessment, monitoring, and stakeholder notification.
Develop, implement, and approve the Risk Assessment framework for all operational and supply chain processes.
- Team Leadership & Management
Manage QA Compliance team performance, including hiring, training, and career development for the QA Specialists.
Mentor and guide the team, fostering a culture of quality, precision, and continuous learning.
Represent the QA Compliance function in senior leadership meetings, external client audits, and regulatory authority inspections (e.g., TFDA).
Handle budget forecasting and resource management for the department.
- Client and Stakeholder Engagement
Set the strategy for client and customer engagement on quality topics, including leading Quality Business Reviews (QBRs) for key pharmaceutical principals.
Act as the final approval authority for key quality decisions, such as major deviations and vendor qualifications.
Serve as a dedicated strategic QA contact window for clients, managing special requests (e.g., GDP data reporting, complex questionnaires) and consolidating materials for regular management reviews.
- Operational Compliance
Ensure all medical devices and pharmaceutical products stored in the Distribution Center are safe, compliant, and managed according to the highest quality standards.
Handle client complaint classification, detailed review, and statistical trend analysis to identify and resolve systemic issues (e.g., product damage, inbound discrepancies).
Oversee quarantine processes, retention sample management, and the rigorous handling of Product Quality Complaints (PQC).
Qualification related activities : Computer System Validation, Cold chain, warehouse…..
New Project Management
Warehouse Management
Transportation & Return process management
Must-Have:
Advantage to Have:
What we offer :
- We are committed to fostering an inclusive environment where our employees can learn, grow, and achieve shared success.
- We champion diversity, equity, and inclusion, ensuring every individual feels valued, respected, and treated fairly.
- As a leading multi-market healthcare solutions provider, we empower our employees to gain comprehensive knowledge and expertise in the dynamic healthcare industry across the region.
- Enjoy the flexibility to effectively balance your work and personal life while taking charge of your career journey through our empowering growth opportunities.
- Our Total Rewards program is designed to support your overall well-being in every aspect.
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