GCP Strategy Lead

Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people's varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.The Position The Opportunity Are you ready to take your passion for Quality Assurance beyond audits and make a real impact on patients' lives? Join Roche's Product Development Quality (PDQ) team as a GCP Quality Lead in our GCP Strategy group. You'll have the chance to play a key role in ensuring our medicines reach patients safely and swiftly by leveraging innovative strategies, data analytics, and strong partnerships with stakeholders. Your work will be central to maintaining transparency with health authorities and driving high standards in our non-clinical, clinical, pharmacovigilance, and computerised systems activities. Key Responsibilities:

• Design and Implement Quality Strategies: Shape and apply quality frameworks to support patient safety and regulatory compliance.
• Collaborate with Stakeholders: Build strong relationships to ensure seamless communication across the organisation.
• Risk Assessment: Identify and address risk areas proactively, providing strategic insights to leadership.
• Lead Audits & Quality Activities: Oversee the preparation and execution of quality audits, ensuring compliance and improvements.
• Support Inspections: Lead and contribute to health authority inspections, including preparation and presenting evidence of quality assurance strategies.
• Drive Process Improvements: Group individual findings into system-wide improvements and drive strategic changes.
• Mentorship & Training: Mentor junior staff and provide training on quality standards and audit processes.
Who You Are
• You are a highly motivated and committed professional with a background in scientific or quality fields, holding extensive experience in GCP systems and processes. Your knowledge of regulatory requirements, strong leadership skills, and project management expertise set you apart.
• You have proven critical thinking and problem solving skills (curiosity, creativity and adaptability), with solid relationship management and influence. You ask the challenging questions and are comfortable in difficult conversations.
• You bring a problem-solving mindset and are passionate about using data and innovative quality strategies to improve drug development processes.
• Experience in supporting regulatory inspections and proficiency in data analysis and visualisation tools are highly valued in this role.
Ready for your next challenge? Join our dedicated team and help shape the future of Quality Assurance in Roche. Your Application Please provide your current compelling CV & Cover Letter. The interview process will consist of a screening video interview, followed by a case study presentation as part of the interview process.Who we are At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity. Our UK Pharmaceutical head office is situated in Welwyn Garden City, Hertfordshire, with beautiful countryside surrounding the area. Supported by major motorways & airports as well as being a 30 minute train ride to London, access is easy. Our award-winning office, known as Hexagon Place, was opened in 2005 and provides a modern, flexible working environment with facilities that are second-to-none. Around 2,000 people work at our Welwyn office in Global Early Development (pRED), Global Product Development (PD), Commercial (Rx) and our Corporate functions. Roche offer a competitive salary plus the excellent benefits you would expect from a blue-chip organisation. There is a fully equipped gym on-site, a library and information centre, and an active sports and social club. We also have a subsidised staff restaurant providing foods to cater for every taste throughout the day. At the heart of the building is an informal meeting area known as The Street which features a coffee shop, snack machine and cashpoint. A second building on-site, called The Hub, contains modern meeting room and conference facilities. Roche promotes personal well-being and work-life balance. Therefore, flexible working options will be considered for all roles at Roche UK. Roche is committed to creating a diverse & inclusive environment. 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. 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.


• You are a highly motivated and committed professional with a background in scientific or quality fields, holding extensive experience in GCP systems and processes. Your knowledge of regulatory requirements, strong leadership skills, and project management expertise set you apart.
• You have proven critical thinking and problem solving skills (curiosity, creativity and adaptability), with solid relationship management and influence. You ask the challenging questions and are comfortable in difficult conversations.
• You bring a problem-solving mindset and are passionate about using data and innovative quality strategies to improve drug development processes.
• Experience in supporting regulatory inspections and proficiency in data analysis and visualisation tools are highly valued in this role.
Ready for your next challenge? Join our dedicated team and help shape the future of Quality Assurance in Roche.

Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people's varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters., At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity. Our UK Pharmaceutical head office is situated in Welwyn Garden City, Hertfordshire, with beautiful countryside surrounding the area. Supported by major motorways & airports as well as being a 30 minute train ride to London, access is easy. Our award-winning office, known as Hexagon Place, was opened in 2005 and provides a modern, flexible working environment with facilities that are second-to-none. Around 2,000 people work at our Welwyn office in Global Early Development (pRED), Global Product Development (PD), Commercial (Rx) and our Corporate functions. Roche offer a competitive salary plus the excellent benefits you would expect from a blue-chip organisation. There is a fully equipped gym on-site, a library and information centre, and an active sports and social club. We also have a subsidised staff restaurant providing foods to cater for every taste throughout the day. At the heart of the building is an informal meeting area known as The Street which features a coffee shop, snack machine and cashpoint. A second building on-site, called The Hub, contains modern meeting room and conference facilities. Roche promotes personal well-being and work-life balance. Therefore, flexible working options will be considered for all roles at Roche UK. Roche is committed to creating a diverse & inclusive environment. 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 aaaRoche of personnel so classified. Furthermore, they do not establish a contract for employment and are subject to change at the discretion of Roche. 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 aabp_