Director / Senior Director, GCP Quality Assurance Lead [Remote]

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.

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 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.

How Jobgether works:

We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.

We appreciate your interest and wish you the best!

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