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QA Compliance Manager (f/m/d) 100%

The Swiss based Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of pepTides and oligonucleoTides. As a full service provider Bachem offers products for clinical development and commercial applications as well as a comprehensive catalog and exclusive custom synthesis. With 50 years of experience and subsidiaries in Switzerland, the United States, the United Kingdom and Japan, Bachem is the partner of choice for the biotech and pharma industry worldwide.  
Bachem. Leading Partner in Tides 

In order to continue our organic growth, we are constantly looking for talent.

To complement our newly established QA department for New Chemical Entities (NCE) we are looking for a motivated Compliance Manager (f/m/d). You will report directly to the department head (Director QA NCE). You will join an exciting, fast-growing company and act as an internal point of contact for compliance issues in NCE customer projects within Bachem.


Your tasks

  • Coordinate and approve quality event records (e.g. deviations, CAPA) regarding GMP-related incidents including using an electronic Quality Management System

  • 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)

  • Evaluate and approve subject matter expert assessments of GMP-related incidents, during root-cause investigation review

  • Ensure compliance with the laws and regulations on GMPs for active pharmaceutical ingredients (APIs) as well as with health authorities- and customer specifications

  • Request regulatory and SOP requirements for execution and support the continuous development of internal requirements to improve GMP-compliance within the organization

  • Evaluate data and prepare adequate level of information in order to escalate potentially critical quality issues to upper Management

  • Analyse Quality Review Performance Indicators during periodical preparation of a quality system management review

 

Your profile

  • Doctorate degree or Master’s degree in biotech, pharmaceutical or chemistry (natural sciences)

  • 3+ years of Quality, Manufacturing, Product Development or Research Experience

  • Experience in the GMP regulated environment (EU-, US-, Swiss GMP regulations), preferably with processes involved in manufacturing and distribution, QA, QC, validation

  • 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 quality events management systems (e.g. MasterControl, Trackwise)

  • Affinity to work with GMP-relevant IT Systems (e.g. LIMS, SAP) to achieve compliance in the management of GMP-relevant operations

  • Knowledge in risk management e.g. use of risk management tools

  • Know-how in data integrity and audit-trail review topics

 

We offer an exciting and challenging position in a dynamic environment that guarantees you diversity. You will be joining a team of qualified specialists and you will be able to develop yourself professionally. At Bachem you are empowered to proactively innovate. In addition, we offer you the opportunity to work in an innovative environment and in a motivated team. You can expect modern terms of employment (e.g. flexible working hours,) and attractive fringe benefits.