Director Quality Assurance Qualified Person

Seeking Talent Near: Amsterdam, Netherlands 

Position Summary:

As the Director, Quality Assurance, Qualified Person you will be responsible for ensuring all medicinal products (from key raw materials to final packaged and labelled drug product) are produced at our GMP compliant Contract Manufacturing Organizations (CMOs) and Contract Service Providers (CSPs) and they are released in accordance with relevant requirements such as the European Union pharmaceutical regulation (Directive 2001/83/EC for Medicinal products for human use), Product Marketing Authorization(s) and customer specific requirements. The successful candidate will release product and distribute product within the European Union (EU) and surrounding countries (i.e., Switzerland and the United Kingdom) by coordinating efforts with designated Responsible Person(s) for Good Distribution Practices compliance. Our EU office of record for the MAA filing, MIA and WDA licensure will be located in the Netherlands and therefore frequent travel to the office will be expected. In addition to travel to CMO/CSP sites for certification/audit responsibilities both insider and outside the EU, travel to our European headquarters located in Switzerland will be necessary as well on a periodic basis.

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:

• 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.
• Proficient in the English and German Language, spoken and written.
• 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:

• Proficiency in the Dutch and French languages is highly desired.
• 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.

Physical Requirements:

While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, see, talk or hear in a standard office environment. Employee must occasionally lift and/or move up to 15 pounds.

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