Director/SeniorDirector,GCPQualityAssuranceLead

## Accountabilities Lead end-to-end GCP quality oversight for all sponsored clinical trials, from protocol review through study closeout and clinical study report approval. Serve as the primary QA interface for CROs and external partners, ensuring consistent quality standards and effective issue escalation management. Oversee inspection readiness activities and lead regulatory inspections (FDA, EMA, MHRA, PMDA), including responses and commitment tracking. Manage quality systems including eTMF oversight, protocol deviations, GxP non-conformances, and CAPA development and resolution. Develop, maintain, and improve GCP SOPs, quality metrics, and KPIs to support continuous improvement and executive reporting. Conduct and oversee audits of clinical sites, vendors, and CROs, ensuring compliance and robust quality agreements. Provide QA leadership and subject matter expertise for GVP and GLP activities, including vendor oversight and compliance monitoring. Contribute to the development and maturation of the Quality Management System (QMS) and promote a culture of proactive quality and compliance. Act as a strategic partner to cross-functional teams and mentor junior QA professionals. Requirements: Bachelor’s degree or higher in life sciences, pharmacy, or related field; advanced degree preferred (MSc, PharmD). 10+ years of GCP Quality Assurance experience within biotech, pharmaceutical, or CRO environments. Minimum 3 years of leadership experience in a director or senior QA role, preferably in biotech or clinical-stage organizations. Strong expertise across GCP, GVP, and GLP frameworks with hands-on audit and inspection experience. Deep knowledge of global regulatory requirements including ICH E6, ICH E2, FDA regulations, EU CTR, and OECD GLP principles. Proven track record of successfully leading regulatory inspections (FDA, EMA, MHRA or equivalent). Experience developing or significantly enhancing Quality Management Systems in a biotech or mid-sized organization. Strong