Quality Assurance Manager GCP (7164)

Quality Assurance Leadership in Life Sciences

CTC is a specialized search and recruitment partner for the Life Sciences industry, serving clients and candidates since 1997. We enable careers by connecting talented professionals with meaningful opportunities, and we support our clients in engaging, retaining, and developing the right talent when needed.

For one of our clients in the area of Basel, we are seeking a dedicated professional to join the team on a fixed-term 12-month contract.

Main Responsibilities

• Act as the dedicated QA representative for clinical study teams, ensuring trial execution complies with international regulations, protocol specifications, and ethical standards across all participating sites and trial partners.
• Oversee and conduct GCP audits, including clinical sites, CROs, and specialized service providers, ensuring all 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; drive continuous improvement by updating quality management system (QMS) policies and operational SOPs.
• Prepare teams for Health Authority inspections, assist in hosting audits, and deliver targeted GCP training modules to internal and external project stakeholders.

Qualifications and Experience

• Relevant working/residency permit or Swiss/EU-Citizenship required.
• 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 expertise in GCP auditing and clinical compliance, with at least 8 years in the industry and 6 years in Quality Assurance GCP.
• Direct experience hosting regulatory authority inspections (e.g., US/European agencies) and performing independent site/vendor audits. Auditor certification is a plus.
• Deep expertise in global GCP standards and clinical trial workflows; working familiarity with adjacent GxP areas (GLP, Pharmacovigilance) is advantageous.
• Excellent organizational abilities, strong cross-functional communication skills, full professional proficiency in English, and willingness to travel for auditing duties.
• Willingness to travel globally.