| Location | Basel, Switzerland |
|---|---|
| Business Sector | Biotechnology |
| Contact email | |
| Job ref | 26838 |
| Published | about 2 months ago |
The Senior GCP Quality Manager is responsible for overseeing Good Clinical Practice (GCP) compliance across Phase III clinical programs. The role provides quality oversight for late-stage clinical trials, including CRO and external partner management, audit activities, and inspection readiness. This position supports cross-functional clinical development activities within a mid-sized biopharmaceutical organization focused on anti-infectives.
Minimum 7 years of experience in GCP Quality within the pharmaceutical or biotech industry
Direct experience supporting or leading Phase III clinical trials
Experience conducting or managing GCP audits (internal and/or external)
Experience providing quality oversight to CROs or external clinical vendors
Demonstrated knowledge of ICH-GCP guidelines
Experience working under EU clinical regulatory framework
Experience within anti-infective therapeutic areas (antibiotics or antifungals)
Experience supporting pharmacovigilance activities
Experience in inspection readiness activities for regulatory authorities
Experience working in a mid-sized biotech company environment
Experience with CAPA management within clinical quality systems
Experience contributing to continuous improvement initiatives in clinical quality systems
Senior-level GCP Quality role focused on Phase III clinical compliance and oversight
Direct involvement in CRO oversight, GCP audits, and regulatory inspection readiness
Exposure to EU-regulated late-stage clinical development programs
Opportunity to work within a focused anti-infectives portfolio (antibiotic & antifungal programs)
Strategic impact on Phase III execution and clinical quality performance
Visibility within a lean Global Quality organization
Long-term pipeline growth aligned with commercial expansion
Maurits van Sloun
? m.vansloun@panda-int.com
? +41 44 551 44 07