Senior PV Quality Specialist

Clinical Practice (GCP)/Medical Device Regulation (MDR) Safety audits and inspections, and fostering a culture of continuous improvement.Key ResponsibiltiesAs 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 systemTraining Management: design and development of training packages, working with key stakeholders to define and implement the most appropriate learning approach and materialsStakeholder 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 activitiesInspection 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 areQuality 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 sharingPassionate 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.LocationThis 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 available12/10/#####Who we areA 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. #J-18808-Ljbffr