Director, Clinical Quality Assurance (GCP)

Key ResponsibilitiesMain Purpose of Job:

The Director Clinical and Pharmacovigilance Quality Assurance will oversee the execution of Clinical and Pharmacovigilance Quality Assurance activities within the company, ensuring activities align with GCP and GVP expectations and the Quality Management System, and works closely with internal and external colleagues to develop systems and processes in-line with regulatory requirements, GCP, GVP. GLP, and internal quality processes, as applicable.

This role will also support GxP internal, external, and supplier audits in accordance with international GxP requirements and Immunocore standards, The role is responsible for working cross-functionally with stakeholders across the business to support the escalation and management of Deviations, Corrective and Preventative Actions (CAPAs), Root Cause Analysis (RCA), as well as ad hoc issues impacting business processes.

The ideal candidate will actively partner with the functions to identify and work on solutions to improve quality. They will leverage his/her experience, understanding of GxP, and interpersonal skills, to proactively contribute to QA oversight activities leading to QMS, GxP, and regulatory compliance. This role will also require someone who can work within a highly innovative, agile and entrepreneurial environment and is able to effectively collaborate while working under pressure to achieve timelines and ensure compliance with QMS and regulatory requirements.

This is an in-office role and can be at either our UK (Oxfordshire) or US locations (Gaithersburg, MD or Conshohocken, PA).

Key Responsibilities:

Lead and provide GCP and GVP Quality Assurance oversight of clinical and pharmacovigilance activities impacting the Quality Management System.

Independently lead internal and external audits as defined by the QA Audit Schedule.

Lead or participate in audits of investigator sites, suppliers and vendors to evaluate processes, systems and procedures for compliance to GxP requirements and IMC Quality standards.

Prepare audit plans, perform and report audit findings to the auditee, Head of Functional area and Head of QA.

Help prepare Investigator Sites for Inspection readiness via On-line or In-Person visits

Assist in managing core clinical and QA processes including being owner for some agreed QMS processes, as applicable.

Evaluate and provide oversight for potential risks, standards and quality principles.

Work cross-functionally with stakeholders across the business to support the escalation and management of Quality Issues, Corrective and Preventative Actions (CAPAs), Root Cause Analysis (RCA), as well as ad hoc issues impacting business processes.

Ensure readiness for FDA and other agency inspections for Clinical Operations, Pharmacovigilance, for Immunocore sites, and contracted vendors, sites and clinics.

Support the Inspection Management Team in preparation for and management of GxP regulatory authority inspections

Assist in establishing processes to ensure Data Integrity and communicate the principles of data integrity for GCP and GVP.

Maintain an up to date knowledge of applicable legislation and regulatory guidelines and provide training to staff on regulatory changes.

Provide in-depth quality reviews of data and documentation, as required.

Lead or support the development and/or revision of QA processes and procedures including SOPs and risk assessment tools

Provide training/mentoring on clinical QA, GCP and GLP standards and expectations as required.

Support the review of quality issues and collaborate cross-functionally to ensure risk-based solutions are implemented in a timely manner.

Partner with functions to find solutions for Quality Issues and audit findings.

Participate in QA and clinical operational meetings to discuss status of audits, planned audits, and CAPA extensions.

Support the review of metrics as part of quarterly QMS review meeting.

Attend and contribute to action items identified as part of weekly Quality Monitoring meetings.

Travel up to 20%, International travel may be required to prepare foreign sites for inspections.

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

Supervisory Responsibility (If applicable):

Will have supervisory responsibilities of direct reports. Oversight of contractors and contract auditors.

Education, Experience and Knowledge:

Essential Qualifications:

BS with at least 10-15 years experience with QMS within pharmaceutical and/or biotech industry

Established GCP QA professional.

Excellent knowledge of GCP (GCLP, GVP, GLP and GMP an advantage).

Strong understanding of quality management systems and (GxP), to ensure compliance with regulatory requirements.

Experience utilizing QMS metrics, KPIs, and QTLs to assess risks to clinical research and drug development processes.

Knowledge of corporate governance, health care regulations, laws and standards.

Strong collaborative, partnering, and interpersonal skills.

Previous experience working in clinical research, biotechnology or the pharmaceutical industry.

Excellent analytical, written and oral communications skills.

Able to foster support and influence all stakeholders throughout the company.

Worked with Microsoft Office at an intermediate level (i.e. Word, Excel, PowerPoint Outlook).

Work authorization in the USA is required

Non-Essential Qualifications:

Previous experience of managing quality systems in the pharmaceutical or biotechnology industry.

Knowledge of GMP, GLP an advantage.

Knowledge of the industry/clinical trial process and drug development.About the CompanyImmunocore (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 industrys 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.