Manager, R&D Quality Audits, Inspections and CAPA

About the role

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.

Pay

Bay Area: $136,340.00 - $176,440.00. Other US Locations: $123,930.00 - $160,380.00. Kite considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package.

Benefits

Benefits include company-sponsored medical, dental, vision, and life insurance plans. For additional benefits information, visit: https://www.gilead.com/careers/compensation-benefits-and-wellbeing. Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.