Director / Senior Director, GCP Quality Assurance Lead

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Director / Senior Director, GCP Quality Assurance Lead based in United States.

This senior leadership role is responsible for driving global GCP quality strategy across late-stage clinical development programs in neurology and rare diseases.
You will act as the primary quality authority for clinical trials, ensuring full compliance from study start-up through inspection readiness and regulatory submission.
The role combines hands-on quality oversight with strategic leadership, partnering closely with Clinical Development, Regulatory Affairs, and Drug Safety teams.
You will oversee cross-functional and outsourced clinical operations, ensuring CRO and vendor alignment with global regulatory expectations.
This position plays a critical role in shaping a proactive, inspection-ready quality culture across clinical programs and external partners.
You will also contribute to broader GxP oversight, including pharmacovigilance and pre-clinical quality assurance activities.

• 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 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.

Benefits:

• Competitive executive compensation aligned with experience and seniority.
• Fully remote flexibility across the US East Coast, Europe, or Israel.
• Opportunity to work on innovative clinical programs in neurology and rare disease.
• High-impact leadership role influencing global clinical quality strategy.
• Flexible work structure with international collaboration across multiple time zones.
• Occasional international travel for inspections, audits, and team collaboration.
• Exposure to cutting-edge GxP systems, global regulatory interactions, and late-stage clinical development programs.