Senior Quality Assurance Professional

1 week geleden

Amsterdam, Noord-Holland, Nederland Acadia Pharmaceuticals Inc. Voltijd

Acadia Pharmaceuticals Inc. is a leading pharmaceutical company seeking an experienced Senior Quality Assurance Professional to join our team.

About the Role

We are looking for a highly skilled and dedicated individual to oversee the quality of our medicinal products in the EU and UK market. The ideal candidate will have extensive experience working as a Qualified Person (QP) with non-sterile medicinal products, managing regulatory inspections, and ensuring compliance with GMP standards.

This is a fantastic opportunity to work with a dynamic team and contribute to the success of our company. If you are passionate about quality assurance and have a strong background in the pharmaceutical industry, we encourage you to apply.

Responsibilities
  • Oversee the certification of all medicinal products for the EU and UK market produced at Contract Manufacturing Organization (CMO) sites
  • Implement and support Quality Management System (QMS) practices, systems, and procedures to ensure batch certification is completed in acceptable timetables and in total compliance with EU, EC, and other applicable regulations
  • Point of contact and host inspections undertaken by regulatory agencies of medicinal products in conjunction with the Acadia GmbH Quality Assurance team
  • Ensure processes and procedures are in place and appropriate for the Acadia GmbH EU Quality Management System
  • Maintain and perform qualification for suppliers of Acadia GmbH materials in compliance with the audit program for applicable medicinal products, excipients, and components
  • Provide guidance and technical assistance for new product introduction and technical transfer of medicinal products to ensure the Product File is maintained and in compliance with EU GMP expectations
  • Participate in the review and ensure conformance to Quality Agreements with CMOs and CSPs for outsourced operations
  • Assess change controls, OOS, and deviations that occur during batch production and quality control to ensure products meet requirements set forth in the market authorization
Requirements

To be successful in this role, you will need:

  • Relevant university degree in a Life Science discipline (i.e., Pharmacy / Chemistry / Pharmaceutical Chemistry, Biochemistry, Pharmaceutical Technology / Pharmaceutical Management)
  • Eligibility to practice as a certified Qualified Person (QP) in the EU
  • Proven experience working as a QP with non-sterile medicinal products for solid and liquid oral administration
  • Experience managing regulatory inspections with the EU and EC Health Authorities
  • Proven ability to manage supplier quality issues and meetings with a multi-discipline group of attendees
What We Offer

We offer a competitive salary package, including a base salary of $120,000 - $150,000 per year, bonus, new hire equity packages, medical, dental, and vision insurance, 401(k) Plan with a fully vested company match, Employee Stock Purchase Plan, 15+ vacation days, 14 paid holidays, and paid parental leave.

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