Director QA - Release Management QP / FvP (f/m/d) 100%

Bachem Holding AG; Bubendorf; Vor Ort; CHF 130’000 - 170’000; Vollzeit

Zusammenfassung

Bachem Holding AG is seeking a Director QA for Release Management to ensure quality assurance and regulatory compliance. The role requires a strong leadership background in GMP environments, with expertise in analytical chemistry and familiarity with both Swiss and international regulations. This position offers flexibility and development opportunities in a dynamic workplace located in Bubendorf.

Leistungen

Flexible working hours and home office options

Employee development opportunities

60% pension fund contribution coverage

Access to the Swibeco benefits platform

Fresh, healthy meals in the staff restaurant

Free sports activities on campus

Qualifikationen

• 10+ years of experience in GMP-regulated environments.
• Fluent in German and English (C1 level).
• Experience managing managers in a multi-disciplinary team.

Aufgaben

• Lead and mentor the QA Release Management team.
• Final release authority for APIs and intermediates.
• Oversee regulatory compliance and quality assurance strategy.

Kenntnisse

Leadership

Regulatory Compliance

Pharmaceutical Law

Analytical Chemistry

Quality Systems

Ausbildung

PhD or MSc in Chemistry, Pharmacy or related Natural Science

Tools

Electronic Quality Management Systems

Jobbeschreibung

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Director QA - Release Management QP / FvP (f/m/d) 100%

Bachem is a leading, innovation-driven company specializing in the development and manufacture of peptides and oligonucleotides. With over 50 years of experience and expertise Bachem provides products for research, clinical development and commercial application to pharmaceutical and biotechnology companies worldwide and offers a comprehensive range of services. Bachem operates internationally with headquarters in Switzerland and locations in Europe, the US and Asia. The company is listed on the SIX Swiss Exchange. For further information, see www.bachem.com .

Join Bachem asDirector 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.
You will ensure regulatory compliance, product integrity, and operational excellence by leading a team of QA professionals.
You will act asQualified Person (QP) and Fachtechnisch verantwortliche Person (FvP) -owning key release decisions for APIs and intermediates.

Key Responsibilities

• 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!

Please note: unsolicited resumes from recruitment agencies will not be considered.