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.
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