Executive Director, Head of Quality Assurance

Full details of the job.

Vacancy Name

Vacancy Name Executive Director, Head of Quality Assurance

Vacancy No

Vacancy No VN675

Employment Type

Employment Type Full Time

Location of role

Location of role Conshohocken, PA
Gaithersburg, MD
Oxford, UK

Department

Department Clinical QA

Key Responsibilities

Key Responsibilities The Head of Quality Assurance (QA) is a senior leadership role responsible for the strategic direction, oversight, and continuous improvement of the Quality Assurance function across a dynamic, research-driven, and commercial biopharmaceutical organization. This individual will provide enterprise-wide leadership, ensuring robust quality systems and compliance with all applicable GxP (Good Practice) regulations across manufacturing, research, and development. The Head of QA will drive new quality initiatives, work cross-functionally to align on priorities, and ensure the organization meets the highest standards of product quality, patient safety, and regulatory compliance.

• To oversee, manage and lead the Quality Assurance Department and take the lead to ensure Immunocore is fully compliant with all appropriate regulatory authorities
• To lead and promote joined up quality thinking and decision making across all internal and external operations.
• To build a high performing, motivated and skilled Quality team capable of delivering to the standards required
• To lead by example, inspire the Quality team to outperform
• To take full accountability for the Quality and Compliance activities for the UK and US teams
• To take lead to ensure Immunocore is fully compliant as a marketing authorization holder, meeting regulatory and quality standards whilst maintaining compliance to GXP and license commitments.
• To take lead on and full accountability for Immunocore's Quality Assurance Management System.
• To assume the Site Subject Matter Expert role, liaising directly with internal and external customers on all subjects related to Quality
• To oversee the Regulatory Authority and Audit Inspections and ensure company is prepared for these inspections.

Key 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 across the organization.
• Collaborate cross-functionally with Manufacturing, Research & Development, Regulatory Affairs, Supply Chain, and other key 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.
• To promote and embed a culture of Quality Assurance excellence and readiness for inspection throughout Immunocore and its partner organizations.
• To conduct external audits of existing contract manufacturers and suppliers and conduct vendor assessment/selection for all new manufacturers, suppliers and providers.
• To develop and maintain and champion electronic QMS system to track and store all of the key elements related to QA (training, QE, NC, CAPA, RCA, etc
• To liaise with the QA team and oversee all aspects of Change Control and deviations from specification and the validation required before changes can be implemented.
• To provide documented feedback relating to all audits and ensure standards are applied and met with follow up training programs and improvements to QA best practice and process within Immunocore.
• To promote a culture where people are focused on quality, compliance, and inspection readiness by design from the start of any company process and to keep the senior leadership informed of any problems relating to QA issues.
• Support and develop Company Training sessions regarding Quality and Compliance in order to promote a culture of quality and compliance.

Supervisory Responsibility:
This position will be responsible for supervisory responsibilities.

Education, Experience and Knowledge:
Advanced degree in life sciences, pharmacy, engineering, or a related field; PhD, MS, or equivalent preferred. BS/BA in life sciences, pharmacy, or related field with appropriate experience and track record.
10+ years of progressive experience in Quality Assurance within the biopharmaceutical industry, with significant leadership experience across both research and commercial environments.
Deep knowledge of global GxP regulations (GMP, GLP, GCP) and experience leading quality systems in both manufacturing and R&D settings.
Demonstrated success in leading cross-functional teams and driving enterprise-wide initiatives.
Strong strategic thinking, problem-solving, and decision-making skills.
Excellent communication (written and verbal), negotiation, and interpersonal skills, with the ability to influence at all levels of the organization.
Proven ability to manage multiple priorities in a fast-paced, evolving environment.

Specific experience and expectations:
Able to develop and lead a QA team responsible for ensuring GXP compliance across all functional areas.
Successfully conducted inspections by FDA, MHRA and other Health Authorities (HAs).
Successfully led organization to resolve findings from inspections by a recognized Heath Authority.
Demonstrated abilities to train others on root cause analysis, QE identification and CAPA resolutions.
Demonstrated ability to identify critical findings from major and minor observations.
A strong team player with the ability to respond to others in a supportive and flexible manner, and a willingness and ability to contribute as an individual subject matter expert conducting audits and other activities.
Possess a sense of urgency and to be able to instill that urgency in the team.
Analytical Thinking - Tackling problems using a logical, systematic and sequential approach, identifying discrepancies and inconsistencies.
Managing Self Performance - Taking responsibility for own performance, clarifying expectations and promptly notifying managers/colleagues of problems affecting potential completion of goals.

About the Company

About the Company Immunocore (NASDAQ: IMCR) is a pioneering, commercial-stage T cell receptor biotechnology company whose purpose is to develop and commercialize a new generation of transformative medicines which address unmet patient needs in oncology, infectious diseases and autoimmune disease. Our leaders in R&D are internationally recognised as some of the biotech industry's most successful drug developers. We are creating not just an environment where great minds can interact but an innovation powerhouse answering the big questions.

Focused on delivering first-in-class biological therapies to patients, we have developed a highly innovative soluble TCR platform. Our ImmTAX molecules underpin a new generation of precision engineered drugs that harness the immune system to treat a broad spectrum of diseases with high unmet medical need, including oncology, infectious diseases and autoimmune diseases.

At Immunocore, we recognize that our employees are our greatest asset. We value the unique contributions each person brings to our team. By embracing Science, Trust, Respect, Integrity, Diversity, and Entrepreneurship (STRIDE), we create an environment where collaboration thrives, ideas flourish, and transformative changes happen. STRIDE represents more than just letters; it embodies our shared identity and drives our mission. We are dedicated to developing breakthrough therapies that transform patients' lives, advancing medicine, and supporting one another in these pursuits.

Immunocore is proud to be an equal opportunity employer. As such, we are committed to fostering an inclusive workplace where everyone feels valued, respected, and empowered. We encourage applications from individuals of all backgrounds, regardless of race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, or any other characteristic protected by law.