Main Responsibilities:
1. Provide QA oversight for GCP/PV/GLP activities within the company and at vendor/investigator sites for assigned studies / compounds
2. Support and coordinate vendor qualification activities, including audits
3. Support continuous improvement of the Quality Management System (QMS) and related processes, including establish and update QMS documents
4. Ensure timely and appropriate management of non-conformances related to relevant GCP/PV/GLP deviations, quality issues, investigations, CAPAs, and change control
5. Ensure audit results are formally tracked, recorded and reported
6. Coordinate and lead internal or external training activities
7. Support departmental and cross-functional compliance initiatives as assigned
8. Act as QA contact person for vendors/investigator sites for related GCP/PV/GLP studies
9. Support and contribute to a risk-based strategy for QA activities (GCP/PV/GLP)
10. Support inspection readiness and Vendors conducting GCP, PV, and GLP activities through review audit findings, CAPA generation and review, and training
11. Support preparation, conduct and follow up of audits and inspections at client sites and partners as required
12. Report critical issues to the Head of Global Quality Management assess their impact and propose risk mitigation as appropriate
13. Establish and manage work orders with external QA consultants and CROs
14. Maintain a high level of knowledge of current GxP regulations
Qualifications and Experience:
15. Relevant working/residency permit or Swiss/EU-Citizenship required
16. Minimum 5 years of experience in the pharmaceutical industry and a minimum of 3 years’ experience in QA GCP/GVP
17. University or master’s degree in pharmacy, chemistry, or equivalent
18. Working knowledge of GCP and PV legislation
19. Knowledge of product development processes and experience in cross-functional teamwork
20. Experience in auditing GCP, PV and GLP, an auditor qualification would be an asset
21. Experience in GCP/GVP related Health Authority Inspections (FDA, BfArM, other HA)
22. Ability to work both independently and collaboratively, well-organized and structured
23. Excellent communication and presentation skills at different levels
24. Fluency in English written and spoken is essential, any other language would be beneficial