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