Associate Director, Head of Quality

Lonza

  • Suzhou, Jiangsu
  • Permanent
  • Full-time
  • 1 month ago
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

Lonza