QA Manager GCP Clinical Quality & Audits

Take ownership of GCP Quality – from audit planning to inspection readiness.

For an international biopharmaceutical company in Basel, we are looking for an experienced QA Manager GCP to strengthen a small, highly involved Quality team for a 12-month assignment. Starting date January 2027.

This is a hands-on role for someone who enjoys being close to the business: conducting and managing audits, supporting clinical studies, interacting with vendors and investigator sites, and ensuring inspection readiness across GCP activities.

Your responsibilities

• Provide QA oversight for GCP activities across assigned clinical studies and compounds
• Plan, conduct and follow up vendor and investigator site audits
• Coordinate external audits and ensure high-quality audit reports and deliverables
• Support Health Authority inspections, including preparation, back-office activities and follow-up
• Act as QA contact for clinical teams, vendors and investigator sites
• Review findings and support investigations, deviations, CAPAs and change controls
• Contribute to risk-based Quality strategies and inspection readiness activities
• Support the continuous improvement of the Quality Management System (QMS)
• Prepare and update relevant Quality documentation
• Lead or support internal and external Quality training
• Work closely with cross-functional and international stakeholders

The position includes approximately five external audits per year plus internal audits and therefore requires willingness to travel internationally.

Your profile
You are an experienced GCP Quality professional who is comfortable taking responsibility personally rather than delegating operational work.

You bring:

• University degree in pharmacy, chemistry, life sciences or a comparable discipline
• At least 8 years of experience within the pharmaceutical or biotechnology industry
• At least 6 years of hands-on QA GCP experience
• Strong knowledge of current GCP regulations and Quality standards
• Solid experience conducting vendor and investigator site audits
• Experience with Health Authority GCP inspections
• Good understanding of QMS, deviations, CAPAs and change control
• Auditor qualification is an advantage
• Knowledge of PV, GLP or GCLP is beneficial but not mandatory
• Excellent spoken and written English

You work independently, remain structured when priorities compete and communicate openly and transparently. You are confident with demanding stakeholders, enjoy working in a small team and are prepared to contribute wherever support is needed.

The assignment

• Duration: 12 months, until 31 December 2027
• Workload: 100%
• Location: Basel on site (3-4 days per week)
• Start: ideally as soon as possible / January 2027