Director / Senior Director, GCP Quality Assurance Lead
New
US East Coast, Europe, or Israel, international collaboration across multiple time zonesFull-TimeDirector
Salary not disclosed
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Job Details
- Experience
- 10+ years
- Required Skills
- GCPQuality Assurance
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 communication and leadership skills with the ability to influence senior stakeholders and cross-functional teams.
- Highly autonomous, structured, and comfortable operating in fast-paced, resource-constrained environments.
- Experience in neurology, rare diseases, or neurodegenerative clinical programs is a strong plus.
Responsibilities
- 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.
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