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…