Senior Quality Assurance – GCP & CAPA Audits (M/F)

On behalf of one of our clients, a recognised player in the pharmaceutical industry, we are looking for a Senior Quality Assurance specialist in GCP audits and CAPA management, for a 6-month assignment in the canton of Vaud.

You will play a key role in managing and optimising audit and CAPA management processes, with the aim of ensuring regulatory compliance, strengthening inspection readiness, and contributing to the continuous improvement of clinical development activities.

Your responsibilities

• Define and deploy a risk-based audit strategy, in collaboration with the GxP Quality teams and various departments.

• Develop, maintain and execute the Master Audit Plan, covering external providers, systems, clinical studies and documentation.

• Conduct internal GCP audits on clinical trials, programmes and quality processes.

• Select, coordinate and supervise external auditors to ensure proper execution of audits.

• Manage the CAPA processes, ensure their follow-up and monitor their effectiveness.

• Coordinate the preparation and support of regulatory inspections (FDA, EMA, MHRA…).

• Integrate a risk-based quality approach in accordance with ICH Q9, ICH E6(R3) and ICH E8(R1) guidelines.

• Develop and monitor quality indicators (KPIs), analyse trends and identify areas for improvement.

• Contribute to the optimisation of quality procedures (SOPs) and the continuous improvement of systems and processes.

Your profile

• Scientific higher education: Bachelor, Master, PharmD, PhD or equivalent training.

• Minimum 5 to 8 years of experience in Quality Assurance in the pharmaceutical or biotechnology industry.

• At least 5 years of experience in conducting and supervising GCP audits (mandatory).

• Recent and significant experience in preparing and managing GCP regulatory inspections (FDA, EMA, MHRA…).

• Minimum 3 years of experience in monitoring CAPA, deviations and Change Controls.

• Excellent knowledge of GCP regulations and GxP requirements.

• Good knowledge of risk-based quality approaches and ICH guidelines.

• Experience with electronic quality systems (Veeva, Ennov or equivalent) highly appreciated.

• Additional experience in GLP audits or other GxP environments is an asset.

• Experience gained in both large organisations and SMEs would be appreciated.

Your strengths

• Excellent analytical, organisational and communication skills.

• Ability to manage cross-functional projects and collaborate with diverse stakeholders.

• Pragmatic, autonomous and solution-oriented approach.

• Critical thinking, rigour and ability to prioritise risks.

• Ability to combine strategic vision with operational involvement.