Associate Director, Head of Quality

1 day ago

Suzhou, Jiangsu, China Lonza Full time CN¥200,000 - CN¥400,000 per year

Quality Assurance


•       Oversee QA operations, including batch release, complaint handling, and cGMP compliance.


•       Represent the site during customer audits and regulatory inspections.


•       Collaborate with cross-functional teams to ensure quality standards in manufacturing.

Quality Control


•      Lead QC functions covering Raw Material, Analytical, Microbiology, Biochemistry, and Environmental Monitoring.


•       Ensure timely testing and release of results, including Certificates of Analysis.


•       Develop and implement QC strategies aligned with business goals.

Quality Compliance


•       Implement and maintain procedures in alignment with global and national cGMP regulations.


•       Translate global quality standards into site-level policies and practices.


•       Maintain site readiness for audits and certifications.

Customer Interface


•       Ensure all quality related customer complaints are investigated and handled in time.


•       Develop insights that can be used to enhance customer satisfaction or other metrics.


•       Identify when company and customer interest may not align and seeks effective solution to resolve or escalate.

Regulatory Affairs


•       Keep the site updated with the recent applicable regulations.


•       Coordinate with all functions to ensure site compliance with the latest requirement and monitor execution of the related action plan.

Strategy & Continuous Improvement


•       Develop long-term and annual quality plans.


•       Lead quality improvement projects in line with the Operational Excellence strategy.


•       Drive strategic initiatives to strengthen quality systems and processes.

Resource Planning


•       Manage department budgets, staffing, and scheduling.


•       Ensure adequate resources are available to meet business and regulatory demands.


•       Prioritize quality initiatives to meet critical timelines.

People & Leadership


•       Build and lead a high-performing quality team across QA, QC, and Compliance.


•       Implement team development, training, and succession plans.


•       Foster a compliant, efficient, and collaborative team culture.

Qualifications   


•       Degree :Master degree,


•       Field of Study: Pharmacy, Chemistry, Biotechnology, Engineering


•       English: Business Fluent


•       Highly Experienced (10+ years) in Leading Senior Quality Function.


•       People management skills


•       Strong communication skills (vocal/written/presentation)


•       Strong execution skills (ability to plan and take activities to closure)


•       Project management skills


•       Strong analytical skills

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