Manager, R&D Quality Audits, Inspections and CAPA (Biopharma)

Location: Foster City, California, United States; ability to travel globally approximately 30%–40% as needed.

Salary: $136,340–$176,440 annually for the Bay Area; other US locations: $123,930–$160,380 annually.

Company

hirify.global is a biopharmaceutical company developing CAR T-cell and T-cell receptor engineered therapies for cancer treatment.

What you will do

• Partner with R&D GCP and GVP groups on regulatory expectations, quality requirements, inspection readiness and CAPA development.
• Lead or support internal R&D, investigator site, vendor and GVP-related quality audits.
• Develop, track and support CAPAs addressing audit findings, inspection observations, deviations and quality events.
• Support regulatory inspection preparation, coordination, response activities and follow-up actions.
• Evaluate SOPs, procedures, data, documentation and reporting for regulatory compliance and quality oversight.
• Coordinate contract auditors, quality training, metrics, reporting and continuous improvement initiatives.

Requirements

• PharmD or PhD with relevant quality and compliance experience; or MA, MS or MBA with 4+ years; or BA or BS with 6+ years of quality and compliance experience.
• Strong GCP auditing experience, including lead auditor experience for investigator site audits.
• Experience with GCP and GVP processes, quality systems, inspection readiness, pharmacovigilance and CAPA management.
• Knowledge of Good Clinical Laboratory Practices and electronic systems compliance.
• Strong analytical, written communication, project management, collaboration and influencing skills.
• Proficiency with Microsoft Office applications and willingness to travel globally approximately 30%–40%.

Nice to have

• Vendor audit and study-level vendor compliance experience.
• Quality Auditor certification or a similar quality-related certification.
• Experience with Lean Six Sigma or total quality management methodologies.
• Experience supporting Kite therapeutic areas and multiple stages of drug development.

Culture & Benefits

• Work in a collaborative, highly matrixed environment with Kite and Gilead partners.
• Support a culture of quality, accountability, transparency and inclusion.
• Eligibility for a discretionary annual bonus and long-term stock-based incentives may apply.
• Benefits may include paid time off and company-sponsored medical, dental, vision and life insurance plans.