Director Quality Assurance

1 maand geleden

Amsterdam, Nederland Acadia Pharmaceuticals Inc. Voltijd
Primary Responsibilities:
  • Batch release/Certification of all medicinal product for the EU and UK market produced at CMO sites ensuring compliance with appropriate GMP standards and Market Authorization
  • Implement and support QMS practices, systems, and procedures to ensure that batch certification is completed in acceptable timetables and in total compliance with EU, EC and other applicable regulations
  • Point of contact and hosting of inspection(s) 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
  • Ensure, maintain and perform qualification for the suppliers of Acadia GmbH materials in compliance with the audit program for the applicable medicinal products, excipients, and components. Perform audits when applicable
  • 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
  • Participates in the review and ensures conformance to Quality Agreements with Contract Manufacturing Organizations and Contract Service Providers for outsourced operations
  • Assessing the change controls, OOS, and deviations that occur during the batch production and quality control to ensure products meets requirements set forth in the market authorization
  • Assess the product quality and management reviews, as well as define actions and post–registration activities, such as ongoing stability studies,  product quality reviews (PQRs), complaints, report of adverse events, and recalls, all of which may influence the product and it’s production process
  • Oversight and coordination with Responsible Person for GDP responsibilities
  • Other duties assigned as needed

Education/Experience/Skills:

  • Proficiency in English and German required
  • Dutch is highly desired
  • Relevant university degree in a Life Science discipline (i.e., Pharmacy / Chemistry / Pharmaceutical Chemistry, Biochemistry, Pharmaceutical Technology / Pharmaceutical Management) as well as 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 is expected
  • Experience managing regulatory inspections with the EU and EC Health Authorities is required
  • Proven ability to manage supplier quality issues and meetings with a multi-discipline group of attendees
  • As mentioned above, travel will be required to fulfil the responsibilities of a Qualified Person and certification of CMO/CSP sites both inside and outside of the EU. Additional travel to our Netherlands and Swiss offices is also required on a periodic basis and as required to fulfil the responsibilities of a Qualified Person.

Desired Requirements:

  • A working knowledge and practical experience with Veeva Quality Docs and QMS systems
  • Background in Swissmedic and/or MHRA inspections
  • Experience managing regulatory inspections with regulators outside of Europe.
  • Knowledge of Swiss and UK regulations in relation to importation of product into and out of the EU
  • Background in aseptically produced sterile, medical device, and drug-device combination products. Background in small molecules, peptides and oligonucleotides

#LI-MS1

 

What we offer you (US-Based Employees):

  • Competitive base, bonus, new hire and ongoing equity packages
  • Medical, dental, and vision insurance
  • 401(k) Plan with a fully vested company match 1:1 up to 5%
  • Employee Stock Purchase Plan with a 2-year purchase price lock-in
  • 15+ vacation days
  • 14 paid holidays plus one floating holiday of your choice, including office closure between December 24th and January 1st
  • 10 days of paid sick time
  • Paid parental leave
  • Tuition assistance

  • Quality Assurance Specialist

    2 maanden geleden

    Amsterdam, Nederland Independent Recruiters Voltijd

    Quality Assurance Specialist needed in the FMCG Industry. An organization in the cosmetics industry who have been around for 15 years is looking for a quality assurance specialist to join their team. In this role, you will manage international quality assurance activities and projects that contribute to safeguarding and further improving the quality of...

  • Quality Assurance Specialist

    4 weken geleden

    Amsterdam, Nederland Independent Recruiters Voltijd

    Quality Assurance Specialist needed in the FMCG Industry. An organization in the cosmetics industry who have been around for 15 years is looking for a quality assurance specialist to join their team. In this role, you will manage international quality assurance activities and projects that contribute to safeguarding and further improving the quality of...

  • Quality Assurance Specialist

    2 weken geleden

    Amsterdam, Noord-Holland, Nederland Independent Recruiters Voltijd

    Quality Assurance Specialist needed in the FMCG ;An organization in the cosmetics industry who have been around for 15 years is looking for a quality assurance specialist to join their team.The quality department oversees all global procedures to guarantee that products are safe and continue to fulfill their quality ; In this role, you will keep an eye on...

  • Quality Assurance Specialist

    2 weken geleden

    Amsterdam, Nederland Independent Recruiters Voltijd

    Quality Assurance Specialist needed in the FMCG ;An organization in the cosmetics industry who have been around for 15 years is looking for a quality assurance specialist to join their team.The quality department oversees all global procedures to guarantee that products are safe and continue to fulf

  • Quality Assurance Specialist

    2 maanden geleden

    Amsterdam, Nederland Independent Recruiters Voltijd

    Quality Assurance Specialist needed in the FMCG Industry. An organization in the cosmetics industry who have been around for 15 years is looking for a quality assurance specialist to join their team.The quality department oversees all global procedures to guarantee that products are safe and continue to fulfill their quality standards.  In this role, you...

  • Quality Assurance Specialist

    2 weken geleden

    Amsterdam, Noord-Holland, Nederland Independent Recruiters Voltijd

    Quality Assurance Specialist needed in the FMCG Industry. An organization in the cosmetics industry who have been around for 15 years is looking for a quality assurance specialist to join their team.The quality department oversees all global procedures to guarantee that products are safe and continue to fulfill their quality standards. In this role, you will...

  • Quality Assurance Specialist

    4 weken geleden

    Amsterdam, Nederland Independent Recruiters Voltijd

    Quality Assurance Specialist needed in the FMCG Industry. An organization in the cosmetics industry who have been around for 15 years is looking for a quality assurance specialist to join their team.The quality department oversees all global procedures to guarantee that products are safe and continue to fulfill their quality standards.  In this role, you...

  • Director Quality Assurance

    2 weken geleden

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

    Primary Responsibilities:Batch release/Certification of all medicinal product for the EU and UK market produced at CMO sites ensuring compliance with appropriate GMP standards and Market AuthorizationImplement and support QMS practices, systems, and procedures to ensure that batch certification is completed in acceptable timetables and in total compliance...

  • Quality Assurance Specialist

    1 maand geleden

    Amsterdam, Noord-Holland, Noord-Holland, Nederland Independent Recruiters Voltijd

    Quality Assurance Specialist needed in the FMCG ;An organization in the cosmetics industry who have been around for 15 years is looking for a quality assurance specialist to join their team.The quality department oversees all global procedures to guarantee that products are safe and continue to fulf

  • Quality Assurance Specialist

    4 weken geleden

    Amsterdam, Noord-Holland, Noord-Holland, Nederland Independent Recruiters Voltijd

    Quality Assurance Specialist needed in the FMCG ;An organization in the cosmetics industry who have been around for 15 years is looking for a quality assurance specialist to join their team.The quality department oversees all global procedures to guarantee that products are safe and continue to fulf

  • Director/partner Audit

    3 maanden geleden

    Amsterdam, Noord-Holland, Nederland Crowe Peak Voltijd

    Crowe Peak Amsterdam is op zoek naar een Director/Partner Audit & Assurance! Jouw rol Jij als Manager/Director/Partner bij Crowe Peak. Samen de perfecte combinatie.Crowe Peak is binnen Nederland een toonaangevend onderdeel van het internationale Crowe Global, één van de leidende accountancy netwerken in de wereld, gevestigd in meer dan 150 landen. Bij ons...

  • Director/partner Audit

    4 weken geleden

    Amsterdam, Noord-Holland, Nederland Crowe Peak Voltijd

    Crowe Peak Amsterdam is op zoek naar een Director/Partner Audit & Assurance! Jouw rol Jij als Manager/Director/Partner bij Crowe Peak. Samen de perfecte combinatie.Crowe Peak is binnen Nederland een toonaangevend onderdeel van het internationale Crowe Global, één van de leidende accountancy netwerken in de wereld, gevestigd in meer dan 150 landen. Bij ons...

  • Quality Assurance Expert

    2 weken geleden

    Amsterdam, Nederland Independent Recruiters Voltijd

    We are currently seeking a skilled Quality Assurance Expert to join the QA team. The organization, which specializes in cosmetics and has a proud 15-year heritage, is committed to maintaining the highest of quality standards. As part of the quality department, you will play a vital role in e

  • Team Lead Quality Assurance

    4 weken geleden

    Amsterdam, Nederland Artsen Zonder Grenzen Voltijd

    **Job Brief**: You are responsible for the performance of the organisation’s quality assurance, expert advice and support regarding quality assurance and the procurement of pharmaceuticals or medical devices or specialised food products by leading, **MSF is an international, independent medical humanitarian organization. We are a non-profit, self-governed...

  • Team Lead Quality Assurance

    2 weken geleden

    Amsterdam, Noord-Holland, Nederland Artsen Zonder Grenzen Voltijd

    Job Brief:You are responsible for the performance of the organisation's quality assurance, expert advice and support regarding quality assurance and the procurement of pharmaceuticals or medical devices or specialised food products by leading,MSF is an international, independent medical humanitarian organization. We are a non-profit, self-governed worldwide...

  • Senior Quality Assurance Specialist

    2 weken geleden

    Amsterdam, Noord-Holland, Nederland Arthur Edward Voltijd

    Senior Quality Assurance Specialist – Amsterdam – Competitive + relocation support Are you a quality assurance specialist who loves luxury products for yourself and your home? Do you juggle projects with ease, overcoming problems and hitting deadlines? Join a brand that creates luxury products for body and home that benefit people and the planet,...

  • Quality Assurance Expert

    1 maand geleden

    Amsterdam, Nederland Independent Recruiters Voltijd

    We are currently seeking a skilled Quality Assurance Expert to join the QA team. The organization, which specializes in cosmetics and has a proud 15-year heritage, is committed to maintaining the highest of quality standards.As part of the quality department, you will play a vital role in ensuring that the products are not only safe but continue to meet the...

  • Quality Assurance Expert

    4 weken geleden

    Amsterdam, Nederland Independent Recruiters Voltijd

    We are currently seeking a skilled Quality Assurance Expert to join the QA team. The organization, which specializes in cosmetics and has a proud 15-year heritage, is committed to maintaining the highest of quality standards.As part of the quality department, you will play a vital role in ensuring that the products are not only safe but continue to meet the...

  • Quality Assurance Specialist regio Amsterdam

    2 maanden geleden

    Amsterdam, Nederland Independent Recruiters Voltijd

    Quality Assurance Specialist needed in the FMCG Industry. An organization in the cosmetics industry who have been around for 15 years is looking for a quality assurance specialist to join their team. In this role, you will manage international quality assurance activities and projects that contribute to safeguarding and further improving the quality of...

  • Quality Assurance Expert

    1 maand geleden

    Amsterdam, Noord-Holland, Noord-Holland, Nederland Independent Recruiters Voltijd

    We are currently seeking a skilled Quality Assurance Expert to join the QA team. The organization, which specializes in cosmetics and has a proud 15-year heritage, is committed to maintaining the highest of quality standards. As part of the quality department, you will play a vital role in e