Director of Quality Assurance

2 dagen 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: 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 with EU and EC Health Authorities, ensuring compliance with regulatory requirements.
  • Supplier Quality Management: Ensure the qualification and maintenance of suppliers, adhering to audit programs and regulatory requirements.
  • Product Quality and Management Reviews: Assess product quality and management reviews, defining actions and post-registration activities to ensure compliance with EU GMP expectations.
  • Regulatory Compliance: Ensure compliance with EU and EC regulations, including GDP responsibilities and quality agreements with Contract Manufacturing Organizations and Contract Service Providers.
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, managing regulatory inspections with EU and EC Health Authorities.
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.


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