Executive Director, Head of Quality Assurance
Immunocore, Gaithersburg, MD, United States
Location of role
Gaithersburg, MD, Radnor, PA, Oxford, UK
Department
Clinical QA
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.
Primary Responsibilities
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
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
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.
Promote and embed a culture of Quality Assurance excellence and readiness for inspection throughout Immunocore and its partner organizations.
Conduct external audits of existing contract manufacturers and suppliers and conduct vendor assessment/selection for all new manufacturers, suppliers and providers.
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 Health 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.
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Gaithersburg, MD, Radnor, PA, Oxford, UK
Department
Clinical QA
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.
Primary Responsibilities
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
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
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.
Promote and embed a culture of Quality Assurance excellence and readiness for inspection throughout Immunocore and its partner organizations.
Conduct external audits of existing contract manufacturers and suppliers and conduct vendor assessment/selection for all new manufacturers, suppliers and providers.
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 Health 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.
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