Senior Director, GCP Quality Assurance

Job Summary:

The Senior Director, GCP Quality Assurance provides strategic leadership and operational oversight for Good Clinical Practice (GCP) Quality Assurance activities supporting the company’s clinical development programs. This role is accountable for ensuring that clinical trials are conducted, documented, and reported in compliance with applicable regulatory requirements, company policies, and global GCP standards while maintaining a continuous state of inspection readiness.

The Senior Director serves as a senior QA leader and strategic partner to Clinical Operations, Regulatory Affairs, Pharmacovigilance, Data Management, Biostatistics, and external service providers. The role is accountable for GCP quality systems, clinical quality risk management, CRO and vendor oversight, audit strategy, inspection readiness, quality metrics, and the maturation of fit-for-purpose GCP processes that embed quality by design across the clinical lifecycle.

Work Arrangement & Location:

Hybrid - This position follows a hybrid work schedule, requiring a minimum of two (2) days on-site per week — currently designated as Tuesday and Wednesday. Additional on-site days may be required based on business needs, team priorities, or leadership direction.

Essential Duties and Responsibilities:

• Define, implement, and continuously mature the GCP QA strategy aligned with clinical development objectives, corporate priorities, and global regulatory expectations.
• Serve as the senior GCP QA partner to Clinical Operations and cross-functional stakeholders, providing strategic guidance on GCP compliance, clinical quality risk management, and inspection readiness.
• Champion a proactive culture of quality, compliance, patient safety, data integrity, and continuous improvement across clinical programs.
• Build, lead, mentor, and develop GCP QA capability and/or external QA resources as the function scales.
• Ensure GCP processes are phase-appropriate, risk-based, compliant, scalable, and suitable for outsourced or hybrid clinical development models.
• Lead or provide senior QA oversight for the development, review, approval, implementation, and lifecycle management of GCP-related SOPs, policies, work instructions, and training materials.
• Provide senior QA oversight for GCP activities conducted internally and by CROs, investigator sites, vendors, and other service providers.
• Serve as sponsor QA counterpart to CRO QA groups and other external partner quality functions, ensuring clear standards, escalation pathways, and issue resolution.
• Lead GCP vendor qualification, risk-based audit strategy, issue escalation, performance oversight, and ongoing vendor governance using risk-based principles.
• Review, approve, and maintain QA oversight of GCP-related quality agreements, vendor oversight plans, audit plans, and CAPA commitments.
• Provide senior QA review of key clinical and regulatory documents, as appropriate, to support clinical development quality and submission readiness.
• Own the risk-based GCP audit program, including CRO audits, investigator site audits, vendor audits, TMF/eTMF audits, and system or process audits as applicable.
• Lead GCP inspection readiness, inspection conduct, response development, commitment tracking, and follow-up; serve as a primary QA contact during health authority inspections.
• Coordinate inspection preparation activities, mock inspections, inspection logistics, response development, CAPA planning, and verification of regulatory observation closure.
• Identify, assess, escalate, and proactively mitigate GCP compliance risks, including protocol deviation trends, vendor performance concerns, audit findings, and inspection readiness gaps.
• Perform other duties and responsibilities as assigned.

Qualifications:

• Education: Bachelor’s degree in a scientific or related discipline; advanced degree preferred.
• 12+ years of progressive GCP Quality Assurance or Clinical Quality experience within a biotech, pharmaceutical, or CRO environment, including significant leadership experience at the Director level or equivalent.
• Minimum 3 years of people management preferred.
• Deep knowledge of global GCP requirements and clinical trial oversight expectations, including ICH E6, FDA regulations, EU Clinical Trials Regulation considerations, and inspection readiness expectations.
• Experience with eTMF, clinical quality systems, and electronic GxP systems; familiarity with 21 CFR Part 11, data integrity principles, and Veeva or similar platforms preferred.
• Demonstrated experience leading or managing GCP audits and regulatory inspections, including inspection preparation, conduct, response development, CAPA oversight, and follow-up.
• Extensive experience overseeing CROs, clinical vendors, investigator sites, and other GCP service providers in outsourced or hybrid development models.
• Experience supporting late-stage, pivotal, or registrational clinical trials and related inspection readiness activities.
• Strong background in risk-based quality management, ICH E6(R3) risk-proportionate approaches, quality metrics, and inspection readiness.
• Experience building, scaling, or maturing GCP QA capabilities in lean, virtual, or growing biotechnology organizations.
• Executive presence and strong cross-functional influence
• Ability to balance compliance, patient safety, data integrity, and operational execution
• Position may require ability to travel 20%+ as needed of time or more including occasional overnight stay driven by business need.