IT Compliance Lead
Immunocore is an innovative and dynamic biotechnology company developing a unique platform of T Cell antigen receptor-based therapeutics, called ImmTAXs, as a novel class of treatments for cancer, infectious and autoimmune diseases.
Immunocore has a well- established pipeline of wholly owned programmes, of world leading science and strong IP position, which has led to discovery collaborations with Genentech, GlaxoSmithKline, Medimmune as well as a co-discovery & co-development partnership with Lilly, and recent investment from the Bill & Melinda Gates Foundation.
We have a position available for a talented & enthusiastic individual who can make a valuable contribution to improving the lives of patients in our established Biotechnology Company. We’re looking for an IT Compliance Lead who will report to the IT Compliance Manager and be responsible for:
- Assisting with delivering & supporting operational activities for all technology-related compliance areas across the organization including GxP compliance, periodic reviews for GxP systems and Information Technology General Controls (ITGCs).
- Working with the wider Immunocore team on enhancing IT quality policies and processes to ensure that the IT function operates secure, robust and compliant systems and services.
- Supporting data protection, data management & similar under the direction of management.
We need someone willing, personable and able to simultaneously support various compliance requests and activities across multiple departments. Activities include:
- Operating, reviewing & maintaining existing processes and documentation e.g. the periodic review of GxP Systems, change control, incident / problem management & IT CAPA.
- Identifying improvements then authoring and implementing for all processes and services.
- Performing risk assessments as required for IT infrastructure, applications and support processes, documenting and resolving any findings.
- Authoring & enhancing support processes and documentation within the IT function for GxP activities.
- Periodic review of ITGC (backup, access management, disaster recovery planning and testing).
- Supporting with the maintenance of IT policies, procedures and WIs.
- Maintaining the IT Systems Register.
- Supporting Validation activities for laboratory-based Systems.
- Supporting with maintenance of the Risk and Controls Matrix (SOX).
- Providing cover when the IT Compliance Manager is unavailable.
Candidates are expected to have:
- An undergraduate degree in the field of computer science, business administration or similar; graduate degree in one these fields or previous employment-based experience.
- A minimum 2 years' experience working in the life sciences / pharmaceutical industry.
- Exposure to working with Quality systems, specifically GxP and/or 21 CFR part 11/GAMP.
- Exposure to or awareness of quality management processes such as ISO9001 and ISO27001.
- Strong communication skills (written and oral), ideally with government/legal agencies and external/internal auditors.
- A proven capability in developing documentation.
- Demonstrable time management & organisational skills.
- Experience with establishing credibility and working relationships
- The ability to present ideas in business-friendly and user-friendly language.
- Thoroughness with good attention to detail.
Immunocore provides a comprehensive benefits package including medical, dental, pension, life insurance, gym membership, cycle to work scheme, etc. If this is an opportunity that you would like to take on, then please get in touch.