Clinical Quality Assurance Lead

About the role

A recruiter for the life sciences industry is looking for a Clinical Quality Assurance Lead for a client based in Basel, on a fixed-term 12-month contract. The role acts as the dedicated QA representative for clinical study teams, ensuring trial execution complies with international regulations, protocol specifications and ethical standards across all sites and partners.

Key responsibilities

• Oversee and conduct GCP audits of clinical sites, CROs and specialized service providers, making sure findings, reports and follow-up actions are completed within target timelines.
• Direct third-party vendor qualification workflows, manage external QA consultant engagements and maintain quality agreements for outsourced clinical activities.
• Lead the investigation and tracking of clinical deviations, quality issues and CAPAs, and update QMS policies and operational SOPs to drive continuous improvement.
• Prepare teams for Health Authority inspections, assist in hosting audits and deliver targeted GCP training to internal and external stakeholders.

Required profile

• Working/residency permit or Swiss or EU citizenship.
• Master's degree (or equivalent) in Life Sciences, Pharmacy, Chemistry or a related scientific discipline.
• Established track record in pharmaceutical Quality Assurance with extensive hands-on GCP auditing and clinical compliance experience.
• Direct experience hosting regulatory authority inspections (e.g. US/European agencies) and performing independent site and vendor audits; auditor certification is a plus.
• Full professional proficiency in English and willingness to travel for auditing duties.

Required skills

• Deep expertise in global GCP standards and clinical trial workflows.
• Familiarity with adjacent GxP areas such as GLP and Pharmacovigilance is advantageous.
• Excellent organizational abilities and strong cross-functional communication skills.