QA Compliance Manager (f/m/d)

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.

we are looking for a motivated Compliance Manager (f/m/d) to join our dynamic QA Department (QA Generics). This role ensures compliance with all relevant national and international GMP regulations as well as with Bachem internal guidelines and its Quality Management System (QMS).

Your tasks

Coordinate and approve quality records (deviations, CAPA, Change controls) with process and product impact
Ensure together with cross-departmental teams a high-level standard of major root-cause investigations and support the establishment of appropriate corrective and preventive actions (CAPA)
Ensure compliance with GMP regulations for active pharmaceutical ingredients (APIs) as well as with Bachem internal guidelines and customer specifications
Evaluate data and prepare adequate level of information in order to escalate potentially critical quality issues to upper Management
Drive continuous improvement in the overall compliance profile. Support the development and implementation of company-wide Quality compliance roadmap

Your profile

University degree in biotech, pharmaceutical or chemistry
3+ years of Quality, Manufacturing, Product Development or Research Experience
Experience in the GMP regulated environment (EU-, US-, Swiss GMP regulations)
Able to interact effectively with people at all levels of the organization, supporting with a solution- and service-oriented attitude
Strong organizational skills with a conscientious and structured way of working and with ability to successfully manage workload and timelines
Very good communication skills (both written and oral)
Very good knowledge of English and German (oral and written expression)

Desirable

Skilled in electronic quality events management systems
Affinity to work with GMP-relevant IT Systems (e.g. LIMS, SAP)
Knowledge in risk management e.g., use of risk management tools

Apply now »