Director QA - Release Management QP / FvP (f/m/d) 100%
Auf einen Blick
- Veröffentlicht:21 Mai 2025
- Pensum:100%
- Vertragsart:Festanstellung
- Arbeitsort:Bubendorf
Bachem ist ein börsenkotiertes, auf die Peptid-Chemie fokussiertes Technologie-Unternehmen mit einem umfassenden Leistungsangebot für die Pharma- und Biotechnologie-Industrie. Bachem ist spezialisiert auf die Entwicklung innovativer, effizienter Herstellungsverfahren und die zuverlässige Produktion Peptid-basierter pharmazeutischer Wirkstoffe. Ein umfangreicher Katalog von Biochemikalien für Forschungszwecke und exklusive Kundensynthesen ergänzen das Angebot. Mit Hauptsitz in der Schweiz sowie Niederlassungen in Europa und den USA ist das Unternehmen weltweit tätig und verfügt über die industrieweit grösste Erfahrung und Fachkompetenz. In der Zusammenarbeit mit ihren Kunden legt Bachem grössten Wert auf Qualität, Innovation und Partnerschaft.
Join Bachem as Director QA - Release Management (QP/FvP) (f/m/d)
Location: Bubendorf, Switzerland | Workload: 100%
Your Impact
As Director QA - Release Management, you will play a pivotal role in shaping Bachem's quality assurance landscape. Leading a team of QA professionals, you will ensure regulatory compliance, product integrity, and operational excellence. You will act as Qualified Person (QP) and Fachtechnisch verantwortliche Person (FvP) - owning key release decisions for APIs and intermediates.
Key Responsibilities
Leadership & Strategy
- Lead, mentor, and grow the QA Release Management team.
- Own the quality assurance strategy for product release and regulatory compliance.
- Actively engage with health authorities and drive compliance initiatives.
- Chair the Quality Review Board (QRB).
Quality Oversight
- Final release authority for APIs and intermediates.
- Approve critical GMP documents, deviations, and validation reports.
- Evaluate and respond to OOS results and regulatory inquiries.
- Ensure robust stability studies and change management processes.
Regulatory Compliance
- Act as QP and FvP per Swissmedic and international regulations.
- Prepare for and lead inspections, audits, and cross-functional quality projects.
- Oversee departmental budget and resource planning.
- Provide expert guidance on GMP, analytical methods, and pharmaceutical law.
Your profile
- PhD or MSc in Chemistry, Pharmacy, or a related Natural Science.
- 10+ years of experience in GMP-regulated environments.
- Proven leadership experience, ideally managing managers and multi-disciplinary teams.
- Strong knowledge of Swiss, EU, and US GMP regulations.
- Fluent in German and English (C1 level).
- Solid understanding of analytical chemistry and quality systems.
- Experience with electronic quality and document management systems.
Our offer:
- A dynamic and rapidly growing work environment with internal development opportunities
- Flexible working hours with home office days and an option for obtaining additional vacation days through workload reduction
- Employee development through numerous internal and external training opportunities
- 60% coverage of pension fund contributions by Bachem AG as well as option for extra-mandatory pension provision with our Pension Plan Plus
- Access to the Swibeco benefits platform with discounts from external partners
- Fresh, healthy and varied food in our staff restaurant
- A wide range of free sports activities on the Bachem Campus
Would you like to drive innovation together with us?
We look forward to receiving your complete application documents via our application portal.
Learn more about the Bachem Group and get inspired by our exciting work environment at our location in Bubendorf!
