Safety and Medical Quality Lead - Observational Research

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Requirements:

• Degree Educated.
• Proven experience in R&D, Operations, and/or Quality in the Pharma/Biotech sector.
• Demonstrated leadership expertise in developing teams and coordinating projects.
• Proven track record with auditing, preferably in GPvP or GCP.
• Good knowledge of global regulatory requirements for GPvP/GCP.

Responsibilities:

• Plan, conduct and report on risk-based GPvP audits.
• Assess and manage risks, including developing the annual GPvP audit plan.
• Provide quality input for risk assessment related to Observational research studies.
• Act as Quality Lead contact for vendor evaluation and oversight in Observational research.
• Support inspections and external audits, and improve R&D processes with CAPA.