Europe Arbeitnow ·
full-timeSr. Manager, Quality Assurance
Acadia Job Listings · Zug
About Acadia Pharmaceuticals Acadia is committed to turning scientific promise into meaningful innovation that makes the difference for underserved neurological and rare disease communities around the world. Our commercial portfolio includes the first and only FDA-approved treatments for Parkinson’s disease psychosis and Rett syndrome. We are developing the next wave of therapeutic advancements with a robust and diverse pipeline that includes mid- to late-stage programs in Alzheimer’s disease psychosis and Lewy body dementia psychosis, along with earlier-stage programs that address other underserved patient needs. At Acadia, we’re here to be their difference. Position Summary: On behalf of Acadia GmbH the Sr. Manager, Quality Assurance Operations will be responsible for oversight of cGMP European operations within a global Quality Assurance department of Acadia Pharmaceuticals Inc. Responsibilities will include oversight of assigned cGMP operations performed at Contract Manufacturing Organizations (CMOs), as well as cGMP European operations performed at Acadia, quality release of API and drug product, raw materials and intermediates intended for commercial and clinical (where required) use. Primary responsibilities include: batch record review and batch disposition, support of product complaints, annual product review / product quality reviews, continuous process verifications (CPV), ensuring conformance to global Acadia standard operating procedures (SOPs) and quality agreements with CMOs, as well as compliance to Swissmedic/EMA/MHRA and other applicable international regulations. Proficient-level user and participant in continuous improvement activities with respect to Acadia global GMP training program, change management, validation activities, batch review and release, complaint handling, CAPA program, GMP audits, and similar related activities. This position reports to the Director, Quality Assurance, Acadia GmbH. Primary Responsibilities: Oversee CMO’s from a quality perspective as assigned and perform review and approval of CMO Quality Documentation. Manages the Acadia batch disposition process of API, Drug Product, Raw materials and Intermediates Participates in design, implementation and management of the Acadia GMP quality management system, based on Swissmedic/EMA/MHRA and other applicable international regulations Ensures compliance of the Acadia GMP quality management system with Swissmedic/EMA/MHRA and applicable international quality management system regulations Serves as a key point of contact with CMO partners and ensures integrated, coordinated activities related to cGMP production and continuous improvement Participates in GMP supplier audits and Acadia documentation control systems as needed Manages and/or provides oversight to QA personnel involved with CMO technology transfer, process validation, batch documentation, registration batch review and process changes and deviations Participates in the review of, and ensures conformance to Quality Agreements with GMP contract service providers for outsourced operations Manages internal investigations and change management and establishes effective CAPA plans and ensure oversight on CMOs investigation a
| Role | Sr. Manager, Quality Assurance |
|---|---|
| Company | Acadia Job Listings |
| Location | Zug |
| Compensation | Not disclosed |
| Deadline | Rolling |
Typical process for this type of role
A general guide — the exact steps for this specific listing may vary; check the original posting for details.
- 1ApplicationSubmit your resume through the apply link.
- 2ScreeningRecruiter reviews your background against the role.
- 3AssessmentA technical test, assignment, or coding round, depending on the role.
- 4Interview(s)One or more rounds with the hiring team.
- 5OfferOffer letter with compensation and start date.
Before you apply
0/4More at Acadia Job Listings
Other jobs at Acadia Job Listings
Explore Related Placements
// similar opportunities
You might also like
Finance Manager
Quantexa
What we’re all about Quantexa is a global leader in AI-powered Decision Intelligence. As one of the UK’s fastest-growing technology companies, we’re on a missio...
Senior Finance Manager
Numan
About Numan Founded in 2018, we’ve already grown to be a 300+ team distributed across the globe, united by a singular mission: empowering people to take control...
0-1 year experience eligible.
Tax Compliance Manager
Taptapsend
About Us We’re building the world’s leading cross-border fintech for emerging markets - empowering families, fueling local economies, and changing how millions ...
Technical Quality Assurance Manager
Bromcom Computers Plc
The Technical QA Manager is responsible for the technical direction, governance and continual improvement of quality engineering across the organisation’s deliv...
Key Account Manager- Quality Assurance
Xebiadach
Ort: Zürich (plus Reisetätigkeit in der Deutschschweiz) Pensum: 80-100% Xebia verschiebt die Grenzen der Möglichkeiten! Wir sind nicht einfach nur Berater – wir...
Manager, ADR - EMEA
Camunda
Camunda is the enterprise platform for agentic orchestration , enabling organizations to coordinate AI agents, people, and systems across complex, end-to-end bu...