Manager, R&D Quality Audits, Inspections and CAPA

As the Manager, R&D Quality Audits, Inspections and CAPA, you will serve as a primary quality and compliance partner for assigned Kite R&D groups, studies, projects and locations. This role supports GCP and GVP quality oversight, internal and investigator site audit execution, inspection readiness, vendor audit awareness and CAPA management. You will partner cross-functionally with Kite stakeholders and Gilead RDQ teams to help ensure R&D activities remain compliant with applicable regulations, Kite’s Quality Management System, internal policies and established procedures. 

Key Responsibilities 

• Serve as a primary quality partner for assigned R&D GCP and GVP teams, providing guidance on regulatory expectations, Kite quality requirements, internal procedures, inspection readiness and CAPA development. 

• Lead or support internal R&D quality audits for assigned groups, processes, vendors or locations, including GCP-focused activities, investigator site audits, internal process audits and GVP-related audits as assigned. 

• Support vendor audit awareness and compliance oversight by partnering with cross-functional teams to understand vendor qualifications, performance trends, audit needs and study-level compliance risks. 

• Develop, track and support effective CAPAs in partnership with cross-functional stakeholders to address audit findings, inspection observations, deviations, quality events and other compliance risks. 

• Support inspection readiness activities, including preparation, coordination, response support and follow-up actions for regulatory or compliance inspections. 

• Evaluate SOPs, procedures, data, documentation and reporting for assigned R&D groups to help ensure regulatory compliance, quality oversight and alignment with business needs. 

• Oversee or coordinate contract auditor activities, including auditor engagement, work direction, documentation review and audit deliverable follow-up. 

• Advise teams on quality systems, processes, documentation, training and CAPA management to support consistent R&D quality practices. 

• Develop and deliver GCP and GVP-focused training for assigned R&D groups and stakeholders. 

• Lead or participate in continuous improvement initiatives related to R&D audits, inspections, CAPA processes, quality systems, policies, procedures and tools. 

• Support quality metrics, reporting and communications related to audit plans, audit outcomes, inspection readiness, CAPA status and quality trends. 

• May support task management, workload coordination or day-to-day guidance for other team members without direct people management responsibility. 

• Promote a culture of quality, accountability, collaboration and inspection readiness across Kite R&D and with external partners and vendors. 

• Ensure assigned work is completed in accordance with applicable regulations, established practices, policies, procedures and business processes. 

Basic Qualifications 

• PharmD or PhD with relevant quality and compliance experience; or 

• MA, MS or MBA with 4+ years of quality and compliance experience; or 

• BA or BS with 6+ years of quality and compliance experience. 

Preferred Qualifications 

• MA, MS or MBA with 4+ years of relevant quality and compliance experience preferred. 

• Strong GCP auditing experience, including experience serving as lead auditor for investigator site audits. 

• Experience supporting or leading internal process audits within GCP, R&D quality, clinical operations or related biopharma functions. 

• Experience supporting inspection readiness, inspection preparation, inspection response activities or inspection follow-up actions. 

• Vendor audit experience or strong working knowledge of vendor qualifications, vendor performance oversight and study-level vendor compliance expectations. 

• Quality, compliance, regulatory or related experience supporting pharmacovigilance, safety, medical affairs, clinical operations or other R&D functions, with strong experience in GCP and GVP. 

• Internal auditing and CAPA development experience within GCP, GVP, pharmacovigilance, safety or related biopharma functions. 

• Experience leading quality, compliance or related projects in the biopharma industry, including process improvements, system enhancements, SOP updates or quality initiatives. 

• Experience working with GCP and GVP processes, systems and quality expectations in a biopharma or related environment. 

• Experience with total quality management methodologies, such as Lean Six Sigma. 

• Experience supporting one or more Kite therapeutic areas and multiple stages of drug development. 

• Quality Auditor certification or similar quality-related certification. 

Knowledge and Other Requirements 

• Strong knowledge of Good Clinical Practices, Good Pharmacovigilance Practices, quality systems, safety reporting, inspection readiness and CAPA management. 

• Working knowledge of Good Clinical Laboratory Practices and Electronic Systems Compliance. 

• Ability to apply sound judgment and flexibility in GCP quality environments where risk evaluation may be situation-specific. 

• Strong analytical thinking, attention to detail, written communication and project management skills. 

• Ability to recognize urgency, escalate key quality or inspection-related issues appropriately and adapt priorities when inspection or compliance activities require immediate attention. 

• Ability to learn quickly, adapt to changing priorities and support multiple projects or business needs. 

• Ability to lead, influence and collaborate across programs, projects and cross-functional initiatives without direct authority. 

• Strong interpersonal skills and ability to work effectively in a highly matrixed, team-oriented environment with Kite and Gilead partners. 

• Transparency, flexibility, accountability and strong communication skills. 

• Proficiency with Microsoft Office applications. 

• Ability to travel globally as needed, estimated at approximately 30% to 40% depending on audit schedules, site availability and business needs.