Director Quality Assurance - Qualified Person (Netherlands)

Director Quality Assurance - Qualified Person (Netherlands)As the 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 inside 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 AuthorizationImplement 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 regulationsPoint of contact and hosting of inspection(s) undertaken by regulatory agencies of medicinal products in conjunction with the Acadia GmbH Quality Assurance teamEnsure processes and procedures are in place and appropriate for the Acadia GmbH EU Quality Management SystemEnsure, 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 applicableProvide 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 expectationsParticipates in the review and ensures conformance to Quality Agreements with Contract Manufacturing Organizations and Contract Service Providers for outsourced operationsAssessing 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 authorizationAssess 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 its production processOversight and coordination with Responsible Person for GDP responsibilitiesOther duties assigned as neededEducation/Experience/Skills:Proficiency in English and German requiredDutch is highly desiredRelevant 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 expectedExperience managing regulatory inspections with the EU and EC Health Authorities is requiredProven ability to manage supplier quality issues and meetings with a multi-discipline group of attendeesAs 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 systemsBackground in Swissmedic and/or MHRA inspectionsExperience 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 EUBackground in aseptically produced sterile, medical device, and drug-device combination products. Background in small molecules, peptides and oligonucleotides

#J-18808-Ljbffr Finance & Insurance