Clinical development quality lead

Company Description

In the context of an increase in activity, one of our clients, a company specialized in the pharmaceutical sector and based in the Canton of Vaud is looking for a Clinical development quality lead.

Job Description

As a Clinical development quality lead, your role will consist to contributes to the implementation of the quality strategy in order to support day-to-day clinical trial activities and providing continuous support and input during the Clinical Development Activities.

Your main tasks will be as follows:

• Develop a risk-based compound-specific compliance program contributing to document
• Contribute to CRO/Vendor selection and qualification process
• Collaborate with the Clinical Trial Manager and other Functional Area Representatives in the Study Team to ensure proper DPI set-up & oversight of outsourced CRO activities
• Provide continuous compliance support by acting as an internal advisor on relevant procedures and regulations to ensure correct interpretation and proper implementation
• Create KQI to identify areas for improvement based on risk-based compliance activities and audit observations
• Lead the specific Regulatory Authority Inspections
• Provide Audit / CAPA support to the execution of Master Audit Plan executed, assist the DPI business stakeholders to ensure proper CAPA formulation and follow-up

Profile

To lead this mission, we are looking for a profile with:

• University Degree in Sciences or relevant academic background
• 6-8 years’ experience in the clinical setting of the pharmaceutical/biotech industry, including at least 3 years within Clinical Quality Management System & Compliance
• Experience in managing and conducting GCP audits
• Excellence knowledge of GCP
• Strong experience in the mechanism of multiple QA vendor’s oversight
• Experience in setting and updating SOPs