Manager, R&D Quality Audits, Inspections and CAPA

Kite Pharma•Foster City, CA

5d•Onsite

About The Position

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.

Requirements

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.
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.
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.

Nice To Haves

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

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.