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Director of Quality Assurance

2 maanden geleden


Amsterdam, Noord-Holland, Nederland Acadia Pharmaceuticals Inc. Voltijd
Job Title: Director Quality Assurance

Acadia Pharmaceuticals Inc. is seeking a highly skilled and experienced Director of Quality Assurance to join our team. As a key member of our quality assurance department, you will be responsible for ensuring the quality and compliance of our medicinal products in the EU and UK markets.

Key Responsibilities:
  • Batch Release and Certification: Ensure the release and certification of medicinal products for the EU and UK markets, adhering to GMP standards and market authorization requirements.
  • Quality Management System (QMS): Implement and support QMS practices, systems, and procedures to ensure compliance with EU, EC, and other applicable regulations.
  • Regulatory Inspections: Host and coordinate regulatory inspections undertaken by EU and EC health authorities, in conjunction with our quality assurance team.
  • Supplier Quality Management: Ensure processes and procedures are in place for supplier quality management, including audits and qualification of suppliers.
  • Product Quality and Management Reviews: Assess product quality and management reviews, defining actions and post-registration activities, such as stability studies, product quality reviews, complaints, and recalls.
  • Regulatory Compliance: Ensure compliance with EU and EC regulations, including GDP responsibilities and coordination with the responsible person.
Requirements:
  • Education and Experience: Relevant university degree in a life science discipline and eligibility to practice as a certified Qualified Person (QP) in the EU.
  • Language Skills: Proficiency in English and German required, with Dutch highly desired.
  • Regulatory Experience: Proven experience working as a QP with non-sterile medicinal products for solid and liquid oral administration, and experience managing regulatory inspections with EU and EC health authorities.
  • Travel Requirements: Travel required to fulfill the responsibilities of a Qualified Person and certification of CMO/CSP sites, both inside and outside the EU.
What We Offer:
  • Competitive Compensation: Competitive base, bonus, new hire, and ongoing equity packages.
  • Benefits: Medical, dental, and vision insurance, 401(k) plan with a fully vested company match, employee stock purchase plan, and paid time off.