Manager, R&D Quality Audits, Inspections and CAPA

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.

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.