Director of Quality Assurance and Compliance

4 dagen geleden


Amsterdam, Noord-Holland, Nederland Acadia Pharmaceuticals Inc. Voltijd
Key Responsibilities:

The Director of Quality Assurance and Compliance will oversee the entire quality assurance process, ensuring compliance with EU and UK regulations. This includes batch release certification, quality management system implementation, and hosting regulatory inspections. The ideal candidate will possess a strong background in pharmaceutical quality assurance, with experience managing suppliers, audits, and regulatory inspections.

  • Batch Release Certification: Ensure compliance with EU and UK regulations for medicinal products produced at CMO sites.
  • Quality Management System: Implement and maintain QMS practices, systems, and procedures to ensure batch certification is completed on time and in compliance with regulations.
  • Regulatory Inspections: Host inspections undertaken by regulatory agencies, working closely with the Acadia GmbH Quality Assurance team.
  • Supplier Management: Ensure processes and procedures are in place for supplier qualification and audits.
  • Regulatory Compliance: Maintain and perform qualification for suppliers of Acadia GmbH materials, ensuring compliance with the audit program for applicable medicinal products and components.
  • Product Quality: Assess the quality of products and management reviews, defining actions and post-registration activities such as stability studies, product quality reviews, complaints, and recalls.


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