Clinical Development Quality Lead

Clinical Development Quality Lead

CK Group are looking for a Clinical Development Quality Lead to join a well-established and successful pharmaceutical company in Switzerland.

This will be a hybrid role, office based in Vaud for three days per week.

This role can be considered on either a permanent or contract basis.

As Clinical Development Quality Lead you will contribute to the implementation of the company’s quality strategy across all clinical trial activities.

Responsibilities :

• Development of a risk-based compliance program.
• Contribution to CRO / Vendor selection.
• Provision of compliance support to internal and outsourced clinical activities, acting as an advisor on relevant procedures and regulations.
• Leading the hosting of Regulatory Authority inspections.
• Supporting the development and maintenance of Quality Management and Clinical Development documentation.

Requirements :

• Extensive clinical operations experience, including QMS and Clinical Compliance work, gained in a biotechnology or pharmaceutical company.
• A relevant life sciences degree.
• In-depth knowledge of GCP, CFR21 and ICH quality requirements.
• Experience of managing and conducting GCP audits.
• Strong experience of the oversight of multiple QA vendors.
• Fluent English and ideally French.

Salary : CHF 140,000-150,000.

CHF 140,000-150,000.