Current jobs related to Manager, Quality Assurance - Oxford, Oxfordshire - Immunocore

  • Quality Assurance Lead

    2 weeks ago

    Oxford, Oxfordshire, United Kingdom Albus Health Full time £60,000 - £120,000 per year

    Albus Health is a nocturnal biomarker company spun out of University of Oxford. We have developed Albus Home, a contactless multisensory platform that monitors a wide range of nocturnal parameters without the patients having to do or wear anything. The product incorporates state of the art sensor technology, with sophisticated machine learning and signal...

  • Manager, Quality Assurance for Quality Control, UK

    2 weeks ago

    Oxford, Oxfordshire, United Kingdom Moderna Full time £60,000 - £80,000 per year

    The RoleJoining Moderna offers the unique opportunity to be part of a pioneering team that's revolutionizing medicine through mRNA technology, with a diverse pipeline of development programs across various diseases.As an employee, you'll be part of a continually growing organization, working alongside exceptional colleagues and strategic partners worldwide,...

  • Principal Product Assurance Manager

    5 days ago

    Oxford, Oxfordshire, United Kingdom Holt Executive Ltd Full time £60,000 - £120,000 per year

    A fantastic opportunity has opened for an experienced Product Assurance Manager to take a leading role across one or more flagship space missions. This position offers the chance to contribute to both flight hardware and software, as well as ground systems, within a cutting-edge In-Orbit Service, Assembly, and Manufacturing programme.This role is available...

  • Quality Assurance Lead

    6 days ago

    Oxford, Oxfordshire, United Kingdom Cure Talent Full time £80,000 - £120,000 per year

    Cure Talent are delighted to be partnered with a rapidly scaling MedTech company developing an advanced contactless monitoring platform used in global clinical research. Their technology combines specialised sensing hardware, embedded software, cloud infrastructure and machine learning analytics to capture high accuracy nocturnal physiological data, and is...

  • Quality & Compliance Manager

    1 week ago

    Oxford, Oxfordshire, United Kingdom Ellison Institute of Technology Full time £60,000 - £80,000 per year

    The Ellison Institute of Technology (EIT) purpose is to have a global impact by fundamentally reimagining the way science and technology translate into end-to-end solutions and delivering these solutions in programmes and platforms that respond to humanity's most challenging problems.EIT will ensure scientific discoveries and pioneering science are turned...

  • Project Quality Lead

    7 days ago

    Oxford, Oxfordshire, United Kingdom Laing O'Rourke Full time £70,000 - £140,000 per year

    *Project Quality Manager – £1bn+ Landmark Scheme | OxfordshireClient:*Blue-Chip Data Centre LeaderLocation:Oxfordshire | Site-BasedShape the future of quality on one of the UK's most ambitious projects.We're delivering a £1bn+ data centre scheme for a global blue-chip client – and we need aProject Quality Managerto set the standard. This is your chance...

  • Principal Software Engineer, Quality

    19 hours ago

    Oxford, Oxfordshire, United Kingdom OrganOx Full time

    ABOUT ORGANOX:OrganOx is an innovative, fast-paced, global medical device company with a mission to save lives by making every donated organ count. We are a commercial stage organ technology company, spun out of the University of Oxford in 2008, committed to improving transplantation outcomes throughout the world. The company's first product, the...

  • Principal Software Engineer, Quality

    1 day ago

    Oxford, Oxfordshire, United Kingdom OrganOx Full time

    ABOUT ORGANOX:OrganOx is an innovative, fast-paced, global medical device company with a mission to save lives by making every donated organ count. We are a commercial stage organ technology company, spun out of the University of Oxford in 2008, committed to improving transplantation outcomes throughout the world. The company's first product, the OrganOx...

  • Quality Systems Officer

    7 days ago

    Oxford, Oxfordshire, United Kingdom OXB Full time £40,000 - £70,000 per year

    Location:Oxford, GBCompany: oxfordbiomJoin Us in Changing LivesAtOXB, our people are at the heart of everything we do. We're on a mission to enable life-changing therapies to reach patients around the world—and we're looking for passionate individuals who embody our core values every day:Responsible, Responsive, Resilient, and Respectful.We are currently...

  • Data Quality Analyst

    2 weeks ago

    Oxford, Oxfordshire, United Kingdom Ellison Institute of Technology Full time £40,000 - £70,000 per year

    Led by a world-class faculty of scientists, technologists, policy makers, economists and entrepreneurs, the Ellison Institute of Technology aims to develop and deploy commercially sustainable solutions to solve some of humanity's most enduring challenges. Our work is guided by four Humane Endeavours: Health, Medical Science & Generative Biology, Food...

Manager, Quality Assurance

2 weeks ago

Oxford, Oxfordshire, United Kingdom Immunocore Full time £80,000 - £120,000 per year

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.