Director Quality Assurance - Qualified Person (Netherlands)

About Acadia Pharmaceuticals

Acadia is advancing breakthroughs in neuroscience to elevate life. For 30 years we have been working at the forefront of healthcare to bring vital solutions to people who need them most. We developed and commercialized the first and only FDA-approved drug to treat hallucinations and delusions associated with Parkinson’s disease psychosis and the first and only FDA-approved drug for the treatment of Rett syndrome. Our clinical-stage development efforts are focused on Prader-Willi syndrome, Alzheimer’s disease psychosis and multiple other programs targeting neuropsychiatric symptoms in central nervous system disorders. For more information, visit us at Acadia.com and follow us on LinkedIn and X.

Position Summary:

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 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:

• 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

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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

EEO Statement (US-Based Employees): Studies have shown that women and people of color are less likely to apply for jobs unless they believe they meet every single one of the qualifications in the exact way they are described in job postings. We are committed to building a diverse, equitable, inclusive, and innovative company and we are looking for the BEST candidate for the job. That candidate may be one who comes from a less traditional background or may meet the qualifications in a different way. We would strongly encourage you to apply – especially if the reason you are the best candidate isn’t exactly as we describe it here.

It is the policy of Acadia to provide equal employment opportunities to all employees and employment applicants without regard to considerations of race, including related to hairstyle, color, religion or religious creed, sexual orientation, gender, gender identity, gender expression, gender transition, country of origin, ancestry, citizenship, age, physical or mental disability, genetic information, legally-protected medical condition or information, marital status, domestic partner status, family care status, military caregiver status, veteran or military status (including reserve status, National Guard status, and military service or obligation), status as a victim of domestic violence, sexual assault or stalking, enrollment in a public assistance program, or any basis protected under federal, state or local law.

As an equal opportunity employer, Acadia is committed to a diverse workforce. If you are a qualified individual with a disability or a disabled veteran, you have the right to request a reasonable accommodation. Furthermore, you may request additional support if you are unable or limited in your ability to use or access Acadia’s career website due to your disability, along with any accommodations throughout the interview process. To request or inquire about your reasonable accommodation, please complete our Reasonable Accommodation Request Form or contact us at [email protected] or 858-261-2923.

Please note that reasonable accommodations granted throughout the recruiting process are not guaranteed to be the same accommodation given if hired. A new request will need to be submitted for any ADA accommodations after starting employment.

Notice for California Applicants: Please see our California Applicant Privacy Notice within our Privacy Policy.

Notice to Search Firms/Third-Party Recruitment Agencies (Recruiters): The Talent Acquisition team manages the recruitment and employment process for Acadia Pharmaceuticals Inc. (“Acadia”). Acadia does not accept resumes from recruiters or search firms without an executed search agreement in place. Resumes sent to Acadia employees in absence of an executed search agreement will not obligate Acadia in any way with the respect to the future employment of those individuals or potential remuneration to any recruiter or search firm. Candidates should never be submitted directly to our hiring managers or employees.