Associate Director, Head of Quality
Role summary
The Associate Director, Head of Quality will oversee all Quality Assurance (QA), Quality Control (QC), and Quality Compliance operations at the Suzhou site. This role is responsible for ensuring cGMP compliance, leading QC functions, managing regulatory affairs, and representing the site during audits and inspections. The Head of Quality will also develop quality strategies, manage department budgets and resources, and lead a high-performing quality team. The position requires a Master's degree in a relevant scientific field, over 10 years of experience in senior quality leadership, and strong people management, communication, execution, project management, and analytical skills.
China, Suzhou
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
Reference: R69271
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