BioPhase

Compensation

Full Description

• Associate Director, Clinical, Pre-Clinical & Diagnostic QA • Remote or Hybrid in Los Angeles, CA • Must have 7+ years of GCP sponsorship auditing The Associate Director will lead quality oversight for the clinical, pre-clinical, and diagnostic programs, ensuring compliance with IBRX SOPs, ICH-GCP, FDA, EMA, MHRA, SAHPRA, and other global regulations. This role manages clinical quality strategies, audit programs, and inspection readiness while supporting cross-functional teams and developing the QMS for Clinical and Preclinical QA. Key Responsibilities • Develop and manage a risk-based GCP audit program and compliance strategy for IBRX studies. • Oversee inspection readiness and support global regulatory inspections (FDA, EMA, MHRA, PMDA, Health Canada). • Lead, mentor, and train Development QA staff, including hiring and auditor development. • Conduct audits, manage quality risks, and drive continuous improvement initiatives. • Investigate and resolve non-conformances, ensuring timely CAPA implementation. • Monitor and report compliance metrics and KPIs to identify trends and risks. • Act as SME on GCP compliance, supporting Clinical Operations, Regulatory Affairs, Medical Affairs, and Pharmacovigilance. • Develop and maintain SOPs, QMS processes, and supplier audit programs. Qualifications • Bachelor’s degree in life sciences or engineering with 8+ years in GCP-regulated biotech/pharma; Master’s with 6+ years acceptable. • Strong expertise in FDA, ICH, and GCP regulations; experience with early-phase trials required, late-phase preferred. • Proven success leading inspection readiness and regulatory hosting activities. • Experience hiring, training, and managing cross-functional QA teams. • ASQ Certified Quality Auditor (CQA) preferred. • Deep knowledge of GCP, clinical QA, and regulatory requirements. • Strong leadership, auditing, and risk management skills.