Inder Bahia
Qa Manager @Kite Pharma
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WORK HISTORY
Qa Manager @Kite Pharma
Santa Monica, CA, US
Engaged in strategic inspection readiness, REMS program operations, and global compliance support across PV and GCP domains. Led and supported global PV and GCP audits across various clinical commercial programs, including investigator sites, vendors and internal systems. Collaborated with global affiliates and external partners to align on PV audit programs and inspection strategies.•Functional SME on REMS implementation, health authority inspection responses, and compliance issue resolution. •Managed REMS certification, audit execution, and compliance tracking for 140+ sites. •Supported submission of REMS annual reports and multiple FDA RFIs.•Managed site qualification under non-FACT pathway, standardizing procedural documents and providing QA oversight.•Led PV affiliate audits, expanding audit scope to cover cell therapy specific risk areas.•Supported audit report turnaround, CAPA management, and effectiveness checks for GCP/PV audits.
EDUCATION
Windsor University School of Medicine
Doctor of Medicine - MD, Medicine
ABOUT INDER BAHIA
Experienced QA Manager with over 5 years in pharmaceutical GxP compliance, currently leading pharmacovigilance audits at Kite Pharma. With a background in medicine and certifications in GCP and human subject research, I bring a unique blend of clinical insight and regulatory expertise. I have successfully managed audit programs, supported HA inspections and led QA teams to ensure compliance with global standards. My prior roles in healthcare operations and clinical research have honed my leadership, analytical, and cross-functional collaboration skills. Passionate about advancing innovative therapies, I strive to enhance quality and patient safety through continuous improvement and strategic quality initiatives.
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