Executive Director, Head of Quality Assurance

Role Summary

Executive Director, Head of Quality Assurance responsible for strategic direction, oversight, and continuous improvement of the Quality Assurance function across a biopharmaceutical organization, ensuring robust quality systems and regulatory compliance (GxP) across manufacturing, research, and development. Provides enterprise-wide leadership to align priorities, drive quality initiatives, and uphold product quality and patient safety.

Responsibilities

• Provide enterprise leadership for the Quality Assurance function, setting the vision and strategy to support both research and commercial operations.
• Identify, propose, and lead new quality initiatives that drive continuous improvement and operational excellence.
• Collaborate cross-functionally with Manufacturing, R&D, Regulatory Affairs, Supply Chain, and other stakeholders to align on initiative scope, timing, resource needs, and prioritization.
• Lead and harmonize quality systems and processes across all GxP areas (GMP, GLP, GCP), ensuring compliance with global regulatory requirements and industry best practices.
• Serve as the primary quality representative in executive leadership forums, providing guidance on risk management, compliance, and quality culture.
• Oversee the development, implementation, and maintenance of quality policies, procedures, and training programs.
• Ensure effective management of internal and external audits, regulatory inspections, and timely resolution of findings.
• Monitor and report on key quality metrics, trends, and risks to senior leadership, driving accountability and transparency.
• Foster a culture of quality, integrity, and continuous improvement throughout the organization.
• Mentor and develop a high-performing QA team, building organizational capability and succession planning.
• Promote a culture of Quality Assurance excellence and readiness for inspection across Immunocore and partner organizations.
• Conduct external audits of contract manufacturers and suppliers; perform vendor assessment/selection for new manufacturers and providers.
• Develop and maintain an electronic QMS system to track QA elements (training, QE, NC, CAPA, RCA, etc.).
• Liaise with QA team and oversee Change Control and deviations from specification and necessary validations before changes.
• Provide feedback on audits and ensure standards are applied with follow-up training and improvements to QA practices.
• Promote a culture focused on quality, compliance, and inspection readiness; keep senior leadership informed of QA issues.
• Support and develop Company Training sessions regarding Quality and Compliance to promote a culture of quality and compliance.

Qualifications

• 10+ years of progressive experience in Quality Assurance within the biopharmaceutical industry, with significant leadership experience across both research and commercial environments.
• Advanced degree in life sciences, pharmacy, engineering, or related field; PhD, MS, or equivalent preferred; BS/BA with appropriate experience accepted.
• Deep knowledge of global GxP regulations (GMP, GLP, GCP) and experience leading quality systems in both manufacturing and R&D settings.
• Proven success in leading cross-functional teams and driving enterprise-wide initiatives.
• Strong strategic thinking, problem-solving, and decision-making skills; excellent written and verbal communication, negotiation, and interpersonal skills.
• Proven ability to manage multiple priorities in a fast-paced, evolving environment.
• Experience developing and leading QA teams to ensure GXP compliance across all functional areas; successful FDA/MHRA inspections and resolution of findings.
• Ability to train others on root cause analysis, quality event identification, and CAPA resolutions; identify critical findings from major and minor observations.
• Team player with ability to contribute as an individual subject matter expert; possess a sense of urgency and ability to instill urgency in the team.

Education

• Advanced degree in life sciences, pharmacy, engineering, or related field; PhD, MS, or equivalent preferred. BS/BA in life sciences, pharmacy, or related field with appropriate experience.