Executive Director, GCP QA (Good Clinical Practice, Quality Assurance)

The Opportunity:

The Executive Director of GCP QA is a senior leadership role responsible for setting and executing the global GCP quality strategy across clinical development programs. This position ensures compliance with regulatory requirements, industry standards, and company policies governing clinical trials. The role provides strategic oversight of GCP QA activities, including leadership of a high-performing QA team, governance of contract research organizations, and advancement of continuous improvement initiatives to uphold the highest standards of quality and patient safety.

Serving as the GCP QA lead for late-stage clinical programs, this individual is accountable for GCP, GLP, and Pharmacovigilance/Safety oversight across multiple RevMed studies and represents QA in cross-functional and executive forums. The Executive Director will serve as a key advisor to senior leadership on clinical quality risk and regulatory readiness, helping to shape development strategy and enable successful regulatory outcomes. This position reports to the Vice President, Global Quality.

Key Responsibilities:

• Develop and execute the global GCP QA strategy aligned with corporate objectives, regulatory requirements, and RevMed SOPs.

• Serve as the Clinical QA Lead for global Phase 2/3 oncology studies, representing QA in governance forums and providing decision-making oversight on GCP related matters.

• Establish and maintain GCP QA frameworks, including policies, procedures, systems, and risk-based quality management (RBQM) to ensure compliance with global regulations (FDA, EMA, ICH).

• Provide end-to-end QA oversight of clinical studies, including:

• Review and approval of key study documents (protocols, monitoring plans, vendor oversight plans, quality agreements)

• Trial Master File (TMF) quality and inspection readiness

• GxP computerized systems and data integrity controls

• Lead and oversee GCP audit and inspection activities, including investigator sites, vendors, internal processes, and regulatory inspections (e.g., BIMO, PV), ensuring timely resolution of findings and CAPAs.

• Serve as the primary QA interface with global regulatory authorities, leading inspection strategy and representing the organization during health authority interactions.

• Drive global inspection readiness through structured planning, mock inspections, and cross-functional preparedness activities to support successful regulatory submissions and approvals.

• Oversee vendor and CRO quality management, including selection, qualification, governance models, performance monitoring (KPIs), and compliance with quality agreements.

• Proactively identify and mitigate systemic quality risks across the clinical portfolio, influencing development strategies and ensuring effective escalation to senior leadership.

• Monitor, trend, and report quality metrics (e.g., KPIs, QTLs, TMF health, CAPAs), leveraging insights to drive continuous improvement and operational excellence.

• Provide QA oversight of pharmacovigilance activities, ensuring compliance with safety reporting requirements and vendor performance expectations.

• Partner cross-functionally with Clinical Development, Clinical Operations, Regulatory Affairs, and Pharmacovigilance to drive quality, compliance, and continuous improvement.

• Drive innovation in QA through adoption of digital tools, advanced analytics, and modern risk-based quality approaches.

• Build, scale, and lead a high-performing global GCP QA organization, fostering a culture of quality, accountability, and operational excellence.

• Serve as a subject matter expert on GCP/GLP/PV regulations, advising senior leadership and influencing quality strategy across the organization.

Required Skills, Experience and Education:

• Advanced degree in life sciences, pharmacy, chemistry, or a related field (PhD, MS, or equivalent preferred).

• Minimum of 15 years of experience in the pharmaceutical or biotechnology industry, including at least 10 years in GCP QA or clinical quality leadership roles, with demonstrated experience leading and hosting regulatory inspections (e.g., FDA BIMO, EMA, MHRA, PMDA).

• Demonstrated experience interacting directly with global health authorities and leading inspection strategy and execution.

• Experience supporting late-stage clinical development and regulatory submissions (e.g., NDA, MAA), preferably in oncology.

• Proven track record and relevant industry experience in leading GCP QA functions within a global organization, preferably in oncology.

• Strong knowledge of global GCP regulations, ICH guidelines, and clinical trial processes.

• Excellent leadership, communication, team building and people skills, with the ability to influence stakeholders at all levels.

• Analytical thinker with a focus on continuous improvement and innovation.

• Experience working within outsourced clinical trial models and managing global CRO/vendor networks is highly desirable.

• This role may require occasional travel (up to 15%) for audits, inspections, and meetings.

• Flexibility to work in a fast-paced, dynamic environment with evolving priorities.

Preferred Skills:

• Experience implementing advanced RBQM frameworks and leveraging analytics-driven approaches (e.g., centralized monitoring, signal detection) to enhance clinical quality oversight.

• Prior experience in a small-to-mid-size biotech environment, with demonstrated ability to build and scale QA functions within highly outsourced, global clinical development models.

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