Senior Group Director, PV Quality Management

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The Position

At Roche, our Global Product Development Safety & Risk Management (PDS) department aims to enhance healthcare for patients by elucidating and communicating the safety profile of Roche medicines to optimise their benefit-risk profile.

The Opportunity

The Senior Group Director of Pharmacovigilance Quality Management (PVQM)  provides strategic leadership, expertise and oversight for the implementation of the QMS within the global PV system and the Pharma Development Safety function.

As a member of the PVSD Leadership Team, the Senior Group Director leads the global PVQM function across Welwyn and Basel.

This role integrates GxP safety knowledge with QMS expertise to support process experts across GVP, GCP, and medical device safety and is a vital enabler for GxP compliance and continued license to operate.

The Senior Group Director is responsible for providing systematic oversight of the QMS for the Roche enterprise-wide PV system, working in strategic partnership with the PD Quality function and the EU QPPV to ensure that all elements of a fully functioning QMS are in place and identifying gaps, driving strategies to close any gaps within the PDS Function.

The Senior Group Director leverages the strengths of a diverse global team and creates an inspiring environment where the PVQM team members feel empowered to take ownership of deliverables, build knowledge and deploy resources effectively, always striving for continuous improvement. 

They are accountable for the implementation and functioning of defined global and/or functional process(es), including associated systems/tools, for the areas of the team's remit.

The PVQM team's remit spans the following main areas:


* The definition, collection, review and actioning of critical QMS and PV system-wide quality and compliance performance measures; 


* The global PV System Master File process and EU PSMF delivery; 


* End-to-end CAPA management of quality events within PDS (deviations/findings) 


* Leadership of inspection activities at the PDS level, providing strategic support and direction and managing documentation requests before and during inspections


* PDS functional processes and training framework, strategy and execution


* PV Business Continuity Management and for compliance risk management at the PDS level. 

Primary Responsibilities and Accountabilities:


* Leadership: Provides line-leadership for the global PVQM sub-function; coaches members to maximise potential and well-...