Global R&D Risk and Compliance Manager in Weybridge

Job Purpose: Risk and Compliance oversight in RDP. Risk Governance of risks owned/monitored by R&D Head and CMO. Center of Excellence for Risk, Compliance and MM in RDP and R&D. As QPPV & Excellence team member, this role may also support QPPV activities as defined under Key responsibilities.

Position Purpose: To ensure and enable compliant organisation and robust inspection readiness by having Risk and Compliance oversight in RDP organisation; ensuring appropriate Risk Governance of risks owned/monitored by R&D Head and CMO through the coordination of risk management forum (i.e., CMO ROC and R&D CRF); and providing expertise and support (Center of Excellence) to RDP and R&D functions in areas of Risk, Compliance and Management Monitoring.

Key Responsibilities:

• Risk and Compliance oversight in RDP: Set, deploy and maintain meaningful KPIs/metrics that enable compliant organisation and drive continuous improvement programmes. Own and drive management monitoring process and have oversight of other relevant controls (e.g. processes/standards, training, etc.) if appropriate. Support RDP responsible in risk management, including identification, control strategy, assessment of residual risk and prioritisation. Coordinate regulatory intelligence monitoring for GVP, GCP and GLP regulatory requirements. May support Haleon QPPV as required, including but not limited to input to PSMF and collection and collation of data for QPPV oversight.
• Risk Governance in RDP and R&D: Establish and maintain appropriate structures and processes of risk management, including SOPs, templates, risk register and charter, and train RDP/R&D responsible accordingly. Set, deploy and maintain meaningful KPIs/metrics that enable monitoring and reporting on the effectiveness of the risk management framework and control. Collect and consolidate relevant information from risk owners into risk management forum to support overall compliance and risk assessment. Coordinate risk management forum, including CMO ROC and R&D CRF, as secretariat.
• Center of Excellence: Be the contact point between Enterprise Risk & Audit and R&D functions. Articulate and communicate risk management principles/model within R&D. Develop supportive materials, including templates and training, to help RDP and R&D functions in Compliance and Risk management.

Key Competencies: A broad scientific/pharmaceutical industry background with relevant experience in R&D functions such as Clinical, Regulatory, Safety and PV. Ability to effectively communicate at all levels, adapting communication to the audience, and to influence, negotiate and partner with stakeholders. Self-motivated and quick learner who proactively shares knowledge and welcomes knowledge and feedback from other team members. Ability to challenge ways of working, bring new ideas and seek opportunities for continuous improvement. Ability to adapt to a changing business and risk environment. Ability to effectively organise work and prioritise/run several activities in parallel, while remaining responsive to emerging requests. Ability to work independently and proactively towards resolution of complex problems. Demonstrated project management skills and management of complex cross-functional activities. Agility to navigate through a matrix organisation, with the ability to remove silos, inefficiencies and ambiguity by bringing clarity and a pragmatic view. Agility with data, including KPIs and metrics, with the ability to identify relevant measures, analyse them and create meaningful reports and relevant actions/continuous improvement. Agility with quality tools, risk management tools and IT systems.

Skills & Experience: Life Science or equivalent degree. Minimum 8 years’ experience in management of Risk, Compliance and Quality in R&D functions, such as Clinical, Regulatory, Safety or PV.