Global R&D Director - Risk and Compliance

Job Description

Responsibilities

• Ensure and enable a compliant organisation and robust inspection readiness across RDP
• Provide risk and compliance oversight, coordinating governance for risks owned or monitored by the R&D Head and CMO
• Act as a Centre of Excellence for Risk, Compliance and Management Monitoring across RDP and R&D
• Build, lead, coach and develop an efficient and motivated team
• Manage team budget, resources and operational activities
• Set, deploy and maintain meaningful KPIs and metrics
• Own and drive the management monitoring process
• Support RDP stakeholders in risk management
• Oversee the regulatory intelligence process for GVP, GCP and GLP regulatory requirements
• Establish and maintain appropriate risk management structures and processes
• Collect and consolidate relevant information from risk owners
• Coordinate risk management forums
• Act as the key contact point between Enterprise Risk & Audit and R&D functions
• Articulate and communicate risk management principles and frameworks across R&D
• Develop supportive materials to strengthen compliance and risk management

Requirements

• Degree in Life Sciences or equivalent
• Minimum 15 years of experience in Risk, Compliance and Quality management within R&D functions
• Broad scientific or pharmaceutical industry background with strong experience across R&D environments
• Demonstrated project management capability, including management of complex cross-functional activities
• Strong data and KPI capability, including identifying relevant measures, analysing trends and producing meaningful reports and actions
• Experience using quality tools, risk management tools and relevant digital systems
• Experience supporting QPPV activities, including contribution to the Pharmacovigilance System Master File (PSMF)
• Experience establishing or maturing risk governance frameworks in matrixed global organisations
• Experience designing and delivering compliance or risk management training across diverse stakeholder groups