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 studiesprojectsand locations. This role supports GCP and GVP quality oversight internal and investigator site audit execution inspection readiness vendor auditawarenessand CAPA management. You will partner cross-functionally with Kite stakeholders and Gilead RDQ teams to help ensure R&D activitiesremaincompliant with applicable regulations Kites Quality Management System internalpoliciesand 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 inspectionreadinessand 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 processauditsand GVP-related audits as assigned.

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

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

• Supportinspectionreadiness activities including preparation coordination responsesupportand follow-up actions for regulatory or compliance inspections.

• Evaluate SOPs procedures datadocumentationand reporting for assigned R&D groups to help ensure regulatory compliance qualityoversightand alignment with business needs.

• Oversee or coordinate contract auditor activities including auditor engagement work direction documentationreviewand audit deliverable follow-up.

• Advise teams on quality systems processes documentationtrainingand 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 orparticipatein continuous improvement initiatives related to R&D audits inspections CAPA processes quality systems policiesproceduresand tools.

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

• May support task management workloadcoordinationor day-to-day guidance for other team members without direct people management responsibility.

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

• Ensure assigned work is completedin accordance withapplicable regulationsestablishedpractices policiesproceduresand business processes.

Basic Qualifications

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

• MAMSor MBA with 4 years of quality and compliance experience; or

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

Preferred Qualifications

• MAMSor 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 clinicaloperationsor related biopharma functions.

• Experience supporting inspection readiness inspection preparation inspection responseactivitiesor 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 clinicaloperationsor other R&D functions with strong experience in GCP and GVP.

• Internal auditing and CAPA development experience within GCP GVP pharmacovigilancesafetyor related biopharma functions.

• Experience leading qualitycomplianceor related projects in the biopharma industry including process improvements system enhancements SOPupdatesor quality initiatives.

• Experience working with GCP and GVP processessystemsand 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 inspectionreadinessand 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 besituation-specific.

• Strong analytical thinking attention to detail writtencommunicationand 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 changingprioritiesand support multiple projects or business needs.

• Ability to lead influence and collaborate across programsprojectsand 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 flexibilityaccountabilityandstrong communicationskills.

• Proficiencywith Microsoft Office applications.

• Ability to travel globally as needed estimated atapproximately 30%to 40% depending on audit schedules siteavailabilityand business needs.