Senior PV Quality Director

In this pivotal role, you'll ensure compliance, deliver quality, and drive strategic projects - overseeing key processes, collaborating with global stakeholders, and playing a crucial role in regulatory inspections. Your deep understanding of Good Pharmacovigilance Practice (GVP) and Good Clinical Practice (GCP) safety requirements will be instrumental in upholding the highest standards of quality and compliance. This is a highly specialised, expert position focused on individual expertise, without direct line management responsibilities.

The Opportunity

• Act as a senior quality leader for our global pharmacovigilance (PV) quality organisation, safeguarding the compliance and quality standards that keep our medicines safe for patients.
• Own key license-to-operate activities, which may include:
• Serving as global process owner for the Pharmacovigilance System Master File (PSMF) - ensuring our safety systems meet Good Pharmacovigilance Practice (GVP) and other applicable requirements worldwide.
• Lead and support GVP and GCP Safety health authority inspections and business partner audits, representing quality and safety with confidence and shaping how we prepare, respond, and continuously improve.
• Drive strategic quality management initiatives and safety process redesign that integrate quality with efficiency, using data and digital tools to lift productivity and compliance.
• Lead integration work streams for mergers and acquisitions, bringing new products and GCP/GVP data into our safety quality framework.
• Collaborate across a global, matrixed organisation - safety, clinical, regulatory, and quality partners - influencing and building consensus without relying on direct authority.
  You bring deep, current knowledge of global GVP/GCP safety regulatory requirements and pharmacovigilance quality management systems.
• You are an excellent systems thinker and process designer, able to design solutions that are both compliant and efficient.
• You have proven experience managing and supporting health authority inspections and audits.
• You lead confidently in a matrix environment, motivating and aligning networked teams without direct line management authority.
• You are a strong, concise communicator and skilled stakeholder manager who uses data and digital tools to drive continuous improvement.
• Together, we'll advance along the whole patient journey with the aspiration to prevent, stop and cure diseases. 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.
  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.