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 Senior Manager, IT Compliance is responsible for ensuring Immunocore’s compliance with regulatory, organizational and commercial requirements covering information technology systems and processes.
- Responsible for dealing with any compliance requests which may be raised or escalated by colleagues.
- Liaising with IT colleagues on current projects within team jurisdiction. Ensuring all IT compliance projects are delivered on time and to budget, logging the progress of projects, ensuring the integrity of data and resolving any issues which may arise.
- Handling business re-prioritisations and customer compliance requests and escalations (including complaints) where necessary.
- Assisting new hires and less experienced staff to become familiar with practices and processes.
- Budget management accountability for IT compliance services, identifying opportunities for cost savings and delivering on these where appropriate.
- Accountable for the implementation of GAMP 5 compliant processes and documentation within the IT function and across all GxP relevant applications in partnership with the business Process Owners.
- Accountable for the maintenance of IT records within the Quality Management System (QMS) including policies, SOPs, WIs, incidents and changes (training will be provided in the QMS).
- Responsible for all IT compliance policies to ensure they are updated, based on any relevant regulatory changes, new laws or best practices.
- Support the Immunocore Privacy framework and Data Protection processes to comply with regulations.
- Evaluate any related external frameworks or standards (e.g., ITIL, COBIT, National Institute of Standards and Technology, etc.) or internal standards (e.g. code of conduct and use) to determine the relevant IT compliance requirements and controls.
Expertise and Knowledge:
- Minimum 5 years' experience working in the life sciences / pharmaceutical industry in similar roles.
- Direct experience of regulatory authority and other audits against IT controls in the life sciences / pharmaceutical industry.
- Significant and demonstrable experience in: Annex 11; FDA 21 CFR Part 11; GxP / GAMP 5.
- Proven capability in developing compliance documentation.
- Proven experience developing and submitting IT audit and compliance reports to governing bodies, legal entities and/or external authorities.
- Demonstrable experience in planning, organizing and developing information technology policies, procedures and practices.
- Strong communication skills (written and oral), including with government/legal agencies and external/internal auditors.
- Ability to translate understanding of the organization's goals and objectives into compliance requirements.
- Demonstrated ability to apply IT-related knowledge and experience in solving compliance issues.
- Significant experience of dealing with sensitive information.
- Demonstrable ability to foster positive relationships with colleagues, proven team and interdisciplinary group working skills.
- Demonstrably effective at handling multiple simultaneous tasks, with associated & changing deadlines.
- Presentation skills & experience, having presented to senior (non-technical) business stakeholders.
Lead with Science and Discover What is Within:
- We value Entrepreneurship and Diversity
- Respect, Trust, and Integrity
- Competitive compensation
- Medical and vision benefits, beginning your first day of employment
- Fully paid Dental Insurance
- 20 days’ vacation plus holidays
- Fully paid Life Insurance and Disability
- 401(k) with Company Match
Candidates must be eligible to work in the U.S. without company sponsorship, now or in the future, for employment-based work authorization. F-1 visa holders with Optional Practical Training (OPT) who will require H-1B status, TNs or current H-1B visa holders will not be considered. H1-B and green card sponsorship is not available for this position.
Immunocore is an E-Verify employer.