Senior Group Director, PV Quality Management

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections,  where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

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-being while sustaining a climate of purpose and urgency

• Strategic Direction: Responsible for defining and articulating vision and strategy for PVQM, in alignment with the overarching PVSD, PDS and wider enterprise strategies

• Partners closely with the PD Quality function and EU QPPV to ensure alignment on QMS strategy, oversight of compliance and management of enterprise compliance issues and risks

• Accountable for ensuring effective, timely and accurate production of the EU PMSF on a regular and ad hoc basis. Also, for ensuring there is an effective process in place for the EU and any required national PSMFs.

• May be personally responsible for assuming a formal role as PDS/PVSD representative on compliance governance bodies (e.g. GXP Council representation) or deputising for the formal representative.

• Resource Management: Oversees recruitment, onboarding, and deployment of PVQM resources across multiple locations based on strategic value

• Stakeholder & Strategy: Partners and maintains relationships with key stakeholders; anticipates future opportunities via internal/external networks. Contributes to PVSD leadership in scenario planning, prioritisation, and budget management

Who you are

• You hold an advanced degree in a relevant discipline, or are a qualified health professional, with strong established experience in PV/safety, and/or Quality

• A post-graduate qualification in an area relevant to PV (e.g. PV Diploma or MSc); quality management and/or business performance management/analysis (e.g. MBA; Lean Sigma certification; Quality or Project Management certification) would be highly desirable.

• You are a highly developed, senior leader, with the proven ability to lead global line- or matrix- teams 

• You have significant business experience in areas directly relevant to PV, clinical quality management, business performance management, business analysis, process management and/or closely related disciplines, and essentially, you have a detailed understanding of QMS and associated approaches

• You can apply analytical thinking to the design, implementation, review and/or delivery of complex, cross-functional processes, measures, metrics, key performance indicators and/or management information system design.

• You utilise highly developed communication and influencing skills to build global collaborations and drive decisions

Location & Travel Requirements

• This position must be based in either Welwyn Garden City in the United Kingdom (preferably) or Basel, Switzerland. Although this can be a hybrid role, with an expectation of ongoing and sustained site presence, in compliance with local company site requirements

• International business travel may be required. Typically, this will be required around 10% of the time, depending upon the site location of the jobholder and/or the requirements of the role for ongoing leadership or business project-related activities

Scientific rigour and creativity, inclusive teamwork and exceptional delivery are key behaviours that drive our mission of doing now what patients need next. Together, we can be transformative.

 

 

Where pay transparency applies, details are provided based on the primary posting location. For this role, the primary location is Welwyn. If you are interested in additional locations where the role may be available, we will provide the relevant compensation details later in the hiring process.Who we are

A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.

Let’s build a healthier future, together.

The statements herein are intended to describe the general nature and level of work being performed by employees, and are not to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. Furthermore, they do not establish a contract for employment and are subject to change at the discretion of Roche Products Ltd. At Roche Products we believe diversity drives innovation and we are committed to building a diverse and flexible working environment. All qualified applicants will receive consideration for employment without regard to race, religion or belief, sex, gender reassignment, sexual orientation, marriage and civil partnership, pregnancy and maternity, disability or age. We recognise the importance of flexible working and will review all applicants’ requests with care. At Roche difference is valued and we are proud to be an equal opportunity employer where you are encouraged to bring your whole self to work.