Capa Project Manager Jobs in California (NOW HIRING)

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,projectsand 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, Kite's 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, data,documentationand 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, documentation,trainingand 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, policies,proceduresand 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, accountability,collaborationand inspection readiness across Kite R&D and with external partners and vendors.

• Ensure assigned work is completedin accordance withapplicable regulations,establishedpractices, policies,proceduresand business processes.

Basic Qualifications

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

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

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

Preferred Qualifications

• MA,MSor 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, pharmacovigilance,safetyor related biopharma functions.

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

• Experience working with GCP and GVP processes,systemsand 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 programs,projectsand 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,accountabilityandstrong communicationskills.

• Proficiencywith Microsoft Office applications.

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