Sr Manager, R&D Quality

Start free →

Or apply yourself on the official page →

About the role

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.   Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.   We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together. Job Description   The Sr. Manager, R&D Quality will lead and support the execution of GxP audits and inspection readiness activities across Kite’s R&D operations, with a focus on Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GVP). This role will be based in Stockley Park and will support both EU and Rest of World (RoW) audits, compliance and regulatory compliance efforts. The incumbent will contribute to the development and implementation of the annual audit program and play a key role in audit management, regulatory inspections and continuous improvement initiatives Key Responsibilities ·       Lead internal GxP audits and inspection readiness activities across assigned R&D functions and geographies. ·       Act as the primary point-of-contact for regulatory inspections in the EU and RoW regions. ·       Provide expert guidance on GCP and GVP compliance, including evolving regulatory requirements. ·       Develop and manage CAPAs resulting from audits, inspections, incidents, and deviations. ·       Contribute to the development and communication of the R&D Annual Audit Program. ·       Represent Kite during regulatory inspections and interactions with health authorities. ·       Lead or participate in cross-functional quality improvement projects and forums. ·       Provide training and mentorship to junior team members and cross-functional partners. ·       Collaborate with global teams to ensure harmonized quality standards and practices. ·       May serve as a Compliance Lead for assigned Kite R&D groups, teams, workstreams or projects ·       Expected 30% to 50% travel Qualifications ·       Bachelor’s or advanced degree in life sciences or related field. ·       Relevant experience in the biopharmaceutical industry, including significant experience in quality, compliance, auditing, and CAPA management. ·       Knowledge of the drug development process and application of the principles, concepts, practices, and standards of Good Clinical Practices (GCP), Good Clinical Laboratory Practices (GCLP), Good Pharmacovigilance (GVP) and Electronic Systems Compliance (ESC).  Experience leading audits and inspections in the EU and RoW regions. ·       Strong knowledge of Quality Management Systems (QMS) and Quality Risk Management (QRM). ·       Proven ability to analyze complex systems and data to identify compliance risks and recommend solutions. ·       Excellent communication, leadership, and project management skills. ·       Certification as a Quality Auditor and experience continuous improvement methodologies preferred. ·       Fluent in English; additional European languages are

View the official posting →