R&D QA Associate Director

Jefferson Wells is looking for a R&D QA Associate Director on behalf of a pharmaceutical company based in Milan.

Short description

- Responsible for structuring, implementing and maintaining Good Clinical Practice (GCP) and Good Pharmacovigilance Practice compliance programs and the relevant Quality Management Systems (QMS) to support the clinical trial and pharmacovigilance activities.
- Provides QA oversight to assure clinical trial activities and pharmacovigilance processes are conducted in compliance with applicable regulations and internal policies and procedures.
- Coordinates and/or conducts internal and supplier audits and serves as the point of contact for all internal regulatory inspections.
- Provides support as sponsor QA in case of regulatory inspections to CRO and investigator sites.
- He/she has the responsibility of the inspection readiness program implementation and maintenance and promotes a GCP/GVP compliant environment with internal and external stakeholders while ensuring established quality systems are employed.
- Reporting to Head of Corporate Quality.

Profilo

Requirements

• Bachelors in a scientific or life sciences discipline. A healthcare background and/or an advanced degree preferred.
• Extensive experience (+15 years) of relevant and increasingly responsibility in a GCP quality role, clinical monitoring or equivalent with at least 6 years in quality.
• Deep knowledge of applicable GCP and GVP regulations, Quality Management, Auditing, Regulatory Compliance and designing of GxP Quality Management.
• Demonstrated audit conduct experience is required, including experience supporting regulatory authority inspections.
• Self-directed and able to work effectively across multiple global cultures and with cross functional teams.
• Excellent oral and written communication skills.