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Quality Assurance Manager GCP/PV/GLP

Our client is an innovative mid-size pharmaceutical company with global headquarters in the German-speaking part of Switzerland. A well-funded and stable organisation, our client enjoys the backing of a number of leading, globally recognised institutions. They are currently market leaders in anti-infectives via a global alliances and extensive partner network. We have a long-standing relationship with this company and have placed a number of key people in the organisation in the past, all of whom have given us some great feedback from their time working there.

We are currently looking for a Quality Assurance Manager for a permanent contract based in Basel area, Switzerland.

Main Responsibilities:

  • Provide QA oversight for GCP/PV/GLP activities within the company and at vendor/investigator sites for assigned studies / compounds
  • Support and coordinate vendor qualification activities, including audits
  • Support continuous improvement of the Quality Management System (QMS) and related processes, including establish and update QMS documents
  • Ensure timely and appropriate management of non-conformances related to relevant GCP/PV/GLP deviations, quality issues, investigations, CAPAs, and change control
  • Ensure audit results are formally tracked, recorded and reported
  • Coordinate and lead internal or external training activities
  • Support departmental and cross-functional compliance initiatives as assigned
  • Act as QA contact person for vendors/investigator sites for related GCP/PV/GLP studies
  • Support and contribute to a risk-based strategy for QA activities (GCP/PV/GLP)
  • Support inspection readiness and Vendors conducting GCP, PV, and GLP activities through review audit findings, CAPA generation and review, and training
  • Support preparation, conduct and follow up of audits and inspections at client sites and partners as required
  • Report critical issues to the Head of Global Quality Management assess their impact and propose risk mitigation as appropriate
  • Establish and manage work orders with external QA consultants and CROs
  • Maintain a high level of knowledge of current GxP regulations

Qualifications and Experience:

  • Relevant working/residency permit or Swiss/EU-Citizenship required
  • Minimum 5 years of experience in the pharmaceutical industry and a minimum of 3 years’ experience in QA GCP/GVP
  • University or master’s degree in pharmacy, chemistry, or equivalent
  • Working knowledge of GCP and PV legislation
  • Knowledge of product development processes and experience in cross-functional teamwork
  • Experience in auditing GCP, PV and GLP, an auditor qualification would be an asset
  • Experience in GCP/GVP related Health Authority Inspections (FDA, BfArM, other HA)
  • Ability to work both independently and collaboratively, well-organized and structured
  • Excellent communication and presentation skills at different levels
  • Fluency in English written and spoken is essential, any other language would be beneficial

Would you like to learn more about CTC and the opportunity outlined? Please, get in contact with us: you may either use the 'apply now' button, or write an email to us, or reach out to us on the phone.

 

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