Job description

Computer Systems Validation/Compliance Lead

91 Park Drive, Milton Park, Oxfordshire, OX14 4RY, UK

Immunocore is a late-stage biotechnology company pioneering the development of a novel class of TCR bispecific immunotherapies designed to treat a broad range of diseases, including cancer, infection and autoimmune disease. We are developing a deep pipeline in multiple therapeutic areas, including five clinical stage programs in oncology and infectious disease, advanced pre-clinical programs in autoimmune disease and multiple earlier pre-clinical programs.

It is an exciting time to join Immunocore. Our most advanced oncology therapeutic candidate, tebentafusp, has demonstrated an overall survival benefit in a randomized Phase 3 clinical trial in metastatic uveal melanoma, a cancer that has historically proven to be insensitive to other immunotherapies. The company also recently completed its Initial Public Offering and was listed on the NASDAQ.

The Computer Systems Validation/Compliance Lead performs the following tasks.  This is a 6 months fixed term contract.

  • Supporting the delivery of operational activities for technology-related compliance across the organization including GxP compliance and periodic reviews for regulated systems.
  • Providing administrative support on Information Technology General Controls (ITGCs).
  •  Supporting the Immunocore IT team on enhancing IT quality policies and processes for regulated activities.
  • Reviewing, evidencing and approving documentation to adhere to IT Compliance and regulatory requirements (including GxP & SOX).

 

Qualifications

  • Minimum 2 years' experience working in the life sciences / pharmaceutical industry.
  • Exposure to working with Quality Management Systems, regulations and processes, specifically GxP and/or 21 CFR part 11/GAMP.
  • Strong communication skills (written and oral), ideally with government/legal agencies and external/internal auditors.
  • Proven capability in developing documentation.
  • Demonstrable strong time management & organisational skills.
  • A proven self-starter, personally motivated to make improvements and to help provide consistently high-quality service and support to end users in a challenging, fast-paced environment.
  • Proven team and interdisciplinary group working skills.
  • Demonstrably effective at handling multiple simultaneous tasks, with associated & changing deadlines.

 

Desirable

  • Exposure to SOX.
  • Exposure to IT Security services management.
  • Exposure to or awareness of quality management process such as ISO9001 and ISO27001.
  • Demonstrated ability to apply IT-related knowledge and experience in resolving compliance issues.
  • Understanding of computer systems and integration capabilities.
  • Ability to translate understanding of the organization's goals and objectives into compliance requirements.
  • Solid understanding of project management principles.
  • Experience with and capabilities to support data protection activities (e.g. potential issue management, GDPR, Article 30 maintenance), etc.

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