QA Specialist (GCP)

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.

Non-Negotiable Skills, Qualifications, and Experience

• 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

Desirable Skills, Qualifications, and Experience

• 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

What the Assignment Offers

• 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

Interested in discussing this opportunity confidentially?

Maurits van Sloun

? m.vansloun@panda-int.com
? +41 44 551 44 07