Senior PV Quality Specialist in Welwyn Garden City

Senior PV Quality Specialist### Senior PV Quality SpecialistApply: Welwyn: Full time: Posted Today: End Date: October 12, 2026 (13 days left to apply): 202609-123852At 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# Senior Pharmacovigilance (PV) Quality Specialist Are you ready to lead and inspire in a dynamic role at Roche? As a Senior Quality Specialist, you will play an important role in Roche’s Pharmacovigilance and Quality Management Systems: your mission will support delivery of the highest standards of patient safety and regulatory compliance. Join us to make a significant impact by supporting key license-to-operate activities, such as functional process development and training activitiesGood pharmacoVigilance Practice (GVP)/Good Clinical Practice (GCP)/Medical Device Regulation (MDR) Safety audits and inspections, and fostering a culture of continuous improvement. **Key Responsibilties**As a Senior PV Quality Specialist, key responsibilities include:* **Process Management:** development and update of procedural documentation, working with key stakeholders to streamline processes and enhance quality outcomes as well as meeting regulatory requirements, and maintaining accurate records of the process landscape for the PV system* **Training Management:** design and development of training packages, working with key stakeholders to define and implement the most appropriate learning approach and materials* **Stakeholder collaboration:** build and maintain relationships with key stakeholders (e.g. Global & Business Process Owners, Quality) to align on quality approaches for specific process documentation and training activities* **Inspection readiness:** Supporting activities relating to the conduct of GVP/GCP Safety/MDR audits and inspections, specifically in the area of document request management.* **Other processes in which our team plays a key role include**: Pharmacovigilance System Master File management, PV Compliance Monitoring, GVP Business Continuity Management, Business Risk Management, and management of the deviations/findings and Corrective and Preventive Actions (CAPAs) process; you may also have the opportunity to become involved in these processes. **Who you are*** **Quality experience:** Experience in pharmacovigilance, clinical safety or medical device vigilance related area(s) including quality-related activities; experience in process mapping / development and/or training development is essential, together with knowledge of key regulatory requirements, in particular those relating to quality and quality management systems.* **Collaborative and results driven:** You enjoy building strong relationships with your global stakeholders; you collaborate and influence effectively to deliver quality and results in a matrix environment.* **Analytical and process-focussed:** you can process and manipulate data as well as analyse and report information to stakeholders effectively, to facilitate decisions and knowledge sharing* **Passionate and self-motivated**: You are independent and well organised, with good attention to detail, and can work simultaneously on complex and/or multiple projects/activities with excellent time management skills.* **Location** + This position is based in Welwyn Garden City, UK. Our team follows a hybrid work structure, requiring a fixed number of onsite days per week. + Relocation Assistance is not availableIf you are passionate about quality and think this is the role for you, please apply by 12/10/2026. You must include a covering letter with your application outlining your skills and experience that make you suitable for the position #J-18808-Ljbffr