Executive Director – Head of Clinical Quality Assurance

Executive Director – Head of Clinical Quality Assurance

Requirements

• A post-graduate degree with 15+ years of relevant experience or a Bachelor’s degree with 18+ years of relevant experience in clinical development, clinical quality assurance.
• Broad GCP audit compliance and CQA experience in a biopharma sponsor organization.
• Proven experience in managing oncology compliance programs and building a culture of quality and operational excellence.
• Deep knowledge of QRM, QbD, and QMS is essential.
• Demonstrated ability to implement QRM principles aligned with ICH Q9 and ICH E6 R2/R3 guidelines.
• Hands-on experience with inspection readiness, audit management, and CAPA management programs is required.
• Strong leadership skills, with the ability to influence, coach, and guide colleagues to achieve optimal business outcomes.
• Skilled in translating and communicating complex, high-impact issues to a variety of stakeholders.
• Able to interpret scientific, technical and legal documents and present information effectively to senior audiences.
• Capable of managing multiple priorities independently in a fast-paced environment while ensuring timely and organized deliverables.

Responsibilities

• Provide strategic leadership to the CQA function, including team development, resource planning, process optimization, and budget oversight.
• Oversee global GCP quality activities to ensure accurate, high-quality clinical trial data that supports global development and regulatory submissions.
• Deliver strategic quality management guidance, tools, and resources to clinical teams to promote effective partnerships and trial oversight.
• Lead & partner in the implementation of Quality Risk Management (QRM), Quality by Design (QbD), and electronic Quality Management System (QMS) to support high-quality, compliant, operationally excellent drug development.
• Develop and maintain methodologies and tools for proactive risk identification and management across clinical trials and suppliers.
• Lead the overall strategy to ensure inspection readiness at all times, including inspection preparation and follow-up, and efficiently track Corrective and Preventive Actions (CAPA) and regulatory commitments to completion.
• Support M&A activities by ensuring knowledge transfer, inspection readiness, and risk mitigation for clinical research programs.
• Conduct periodic reviews of critical clinical trial documentation and inspection-related repositories to ensure completeness and compliance.
• Guide and support audit activities, root cause analyses, CAPA development, and drive continuous quality improvement through trend and risk analysis.
• Provide guidance and training on relevant GxP regulations and support training while serving as an expert resource for interpreting global regulations and standards for internal stakeholders.
• Monitor industry best practices and identify opportunities for consistency and operationally excellent standards for CQA and risk management processes.
• Mentor, train and manage department personnel.

Preferred Qualifications

No preferred qualifications provided.