Overview
In this role you will lead GxP audits and inspection readiness across Kite’s R&D operations to uphold GCP and GVP compliance. You’ll coordinate EU and RoW regulatory activities and shape the annual audit program, driving continuous improvement and regulatory readiness. You collaborate with global teams to harmonize quality standards and mentor junior colleagues. This position offers impact on global regulatory engagements and quality governance within a mission-driven company.
Pay / Benefits
- flexible working policy
- two days remote work
- three days onsite
- hybrid work arrangement
Responsibilities
- Lead internal GxP audits and inspection readiness across assigned R&D functions and geographies
- Act as primary point-of-contact for regulatory inspections in the EU and RoW
- Provide expert guidance on GCP and GVP compliance, including evolving regulatory requirements
- Develop and manage CAPAs 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 harmonize 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
Key requirements
- Bachelor’s or advanced degree in life sciences or related field
- Significant experience in quality, compliance, auditing, and CAPA management in biopharma
- Knowledge of GCP, GCLP, GVP and ESC; experience auditing in EU and RoW
- Strong QMS and QRM knowledge
- Ability to analyze complex systems to identify compliance risks and solutions
- Excellent communication, leadership, and project management skills
- Quality Auditor certification and experience with continuous improvement preferred
- Fluent in English; additional European languages a plus
- excellent communication
- leadership
- project management
- GCP
- GVP
- GCLP
Sr Manager, R&D Quality in London employer: GILEAD Sciences
Gilead is an exceptional employer dedicated to creating a healthier world, where every employee plays a vital role in pioneering life-changing therapies. Located in Uxbridge, our collaborative work culture fosters inclusion and empowerment, providing ample opportunities for professional growth and development. With a strong focus on leadership and continuous improvement, Gilead offers a unique environment that encourages innovation and meaningful contributions to global health challenges.
