Senior Quality Assurance Manager
2 dagen geleden
Senior Quality Assurance Manager
About the RoleWe are seeking a highly skilled Senior Quality Assurance Manager to join our team at Kyowa Kirin. In this role, you will be responsible for ensuring the quality of medicinal products distributed in the EMEA region.
Responsibilities- Ensure compliance with GDP/GDP-API & GMP requirements for the distribution of Medicinal Products.
- Implement and maintain Quality Management Systems (QMS) for medicinal product distribution activities.
- Conduct supplier and customer verification management, including onboarding and offboarding processes.
- Execute Quality Assurance of Stock management, including QA oversight of Inbound/Outbound, non-conformities, returns, and stock reconciliation.
- Monitor the quality performance of distribution contractors and propose actions for improvement.
- Drive continuous improvement activities of established QMS to support compliance with licences.
- Implement Kyowa Kirin QA Global Policies and Global/Regional Procedures/Documents relevant to distribution activities.
- Promote prompt and professional communication of key issues to senior management.
- Participate in project management meetings to ensure progress of ongoing tasks and identify deficiencies in distribution-related activities.
- Lead internal and external audits to assess adherence to GMP/GDP/GDP-API product distribution requirements and Kyowa Kirin QA Policies/Procedures.
- Bachelor's degree in Life Sciences or equivalent.
- Minimum 3-5 years' experience in GDP, preferably in a Quality Assurance position at a manufacturing/distribution site.
- Specialist knowledge and experience of pharmaceutical QMS processes and practices.
- Excellent working knowledge of GDPs for the distribution of commercial medicinal products.
- Fluent English language skills, with good level of Dutch verbal and written communication.
- An estimated salary of approximately $85,000 per year.
- The opportunity to work in a dynamic and challenging environment.
- A comprehensive benefits package, including health insurance, retirement plan, and paid time off.
Kyowa Kirin International is an equal opportunities employer. We value diversity and inclusion in the workplace and strive to create an environment where everyone can thrive.
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