Location of role UK- Oxford
Department Clinical QA
Key Responsibilities The Quality Assurance (QA) Manager will primarily provide quality oversight by collaborating with and supporting those departments/functions involved in chemistry, manufacturing and controls (CMC) and good manufacturing practice (GMP) operations pertaining to investigational (IMP) and licensed medicinal products and associated processes at Immunocore.
The QA Manager will work with the established GxP Quality Management System (QMS), with internal colleagues and third parties to ensure the compliance of CMC/GMP processes with the relevant regulatory framework and internal quality requirements.
Where applicable, this role will require the provision of quality oversight and support for departments/ functions/ processes involving research and human tissue management.
Where applicable, this role will influence/ impact wholesale distribution activities and therefore an understanding of the requirements of good distribution practice (GDP) as defined in Directive 2001/83/EC and various national legislation where Immunocore operates, is essential.
Key Responsibilities:
* Provide quality oversight and support for:
* CMC and GMP operations, ensuring compliance to the relevant regulatory framework and internal quality processes
* Management of the Product Specification File (PSF) for IMP
* Commercial artwork management
* Validation activities
* Manage the QP batch release/ certification process for the supply of licensed medicinal product and IMP
* Work with and support management of the QMS which may include acting as the process owner for one or more QMS components:
* Document management
* Deviations
* Change controls
* Supplier quality management
* Investigations, root cause analysis (RCA) and CAPA
* Complaints
* Product recall
* Annual product quality review (APQR)
* Quality technical agreements (QTA)/ QP-QP agreements
* Quality risk management (QRM)
* Continuous improvement
* Conduct internal audits of GxP departments/ functions/ processes as lead/ support auditor per the internal audit schedule
* Conduct supplier audits of third party service providers as lead/ support auditor (excluding those requiring a QP) per the supplier audit schedule
* Maintain current knowledge of applicable legislation and regulatory requirements; this includes the critical understanding and interpretation of the above
* Conduct in-depth quality reviews of internal and third-parties’ CMC/ GMP documentation
* Collaborate with relevant stakeholders for oversight of the internal CMC (and where applicable - Research) facilities and outsourced GMP activities
* Provide training on any aspect of CMC/ GMP-Quality as required.
Education, Experience and Knowledge:
Essential Qualifications:
* Bachelor’s degree or higher qualification in a relevant scientific subject
* Trained and/or certified as an auditor to an internationally recognized standard
* 5 years’ experience in the Quality unit within life sciences and/or the pharmaceutical industry
* Practical experience with QMS and compliance to relevant regulatory standards
* Knowledge and/or experience of quality oversight for CMC lifecycle processes
* Knowledge and/or experience of:
* GMP
* pharmaceutical manufacturing processes (advantageous - sterile injectables)
* drug development
* Proficiency in Microsoft 365 applications at an intermediate level
* Excellent written and verbal communication skills
* Experience of fostering support and influencing stakeholders in an organization
* Experience working collaboratively with existing teams
Non-Essential Qualifications:
* Knowledge and/or experience in:
* human tissue management and research
* manufacture of sterile injectable T-cell antigen receptor-based therapeutics produced in microbial/mammalian cell culture platforms
* GDP - operations or QA
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.