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QA Manager - CMO - Basel - Zurich

QA Manager - CMO - Basel - Zurich

LocationBasel, Switzerland
Business SectorBiotechnology
Contact email
Job ref22212
Published27 days ago

Quality Assurance Manager - Switzerland

Are you an experienced QA professional in Biotech? Join our client in Northern Switzerland, a prominent leader in cell & gene therapy. As a Senior QA Manager, you'll play an important role in upholding exacting quality standards, ensuring unwavering compliance with regulatory mandates, and cultivating a culture of perpetual enhancement.


  • Lead and oversee medium and high-impact quality investigations, including root cause analysis CAPA management.

  • Oversee implementation of new QMS processes

  • Assume the role of change control (CC) lead for operations, guiding change control processes from initiation to successful completion.

  • Provide support for process enhancements resulting from updates to materials, equipment, facility, and biotherapeutic products, including the introduction of new products.

  • Serve as a Subject Matter Expert on deviations and change controls during inspections and audits.

  • Ensure meticulous documentation and precise completion of quality records to maintain compliance.

  • Monitor the progress of quality investigation and change control processes, tracking key performance indicators (KPIs).

  • Closely cooperate with RA and QC department


  • Bachelor's or Master's degree in a relevant scientific discipline, such as Biology, Chemistry, or Pharmaceutical Sciences.

  • Fluent in German and English.

  • Team management skills of at least 5 years.

  • Experience in working with CMOs

  • Background in cell and gene therapy is a plus.

  • Extensive experience (5+ years) in quality assurance within the Biotech industry, with a strong understanding of GMP, GLP, CAPA, and ISO regulations.

  • Experience in Regulatory Affairs is a plus.

  • Willingness and ability to work on-site for a minimum of 4 days per week.

  • Knowledge of machine learning algorithms is a plus.



If you meet these requirements and possess any of the additional qualifications mentioned above, please feel free to send me a message and your CV at j.knemeyer@panda-int.com.