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.
The ideal candidate will leverage his/her experience, understanding of QMS, and interpersonal skills, to proactively contribute to QA oversight activities leading to QMS, GxP, and regulatory compliance. This role will also require someone who can work within a highly innovative, agile and entrepreneurial environment and is able to effectively collaborate while working under pressure to achieve timelines and ensure compliance with QMS and regulatory requirements.
- To manage, maintain, administer, and support the general upkeep of the QMS.
- To administer, issue and track documents within the eQMS.
- Collaborate with stakeholders to develop and distribute GxP staff training files for new joiners.
- Manage tracking systems to ensure that the QMS is in a controlled state and is compliant with policies, SOPs, best practices, and requirements for the following, as applicable:
- Approved Supplier List (ASL)
- Audits (internal/external)
- CVs (GxP Consulants/Contractors)
- QIs, Complaints, Non-Conformances, CAPAs, RCAs, and Change Control
- Provide/update information for the management and distribution of QMS metrics.
- Plan, build, and facilitate QA trainings, as needed.
- Assist with the archival and long-term storage of GxP documents, files, and related materials.
- Support with managing laboratory notebook distribution and scanning across the company.
- Provide backroom QC support during regulatory inspections and external audits.
- At the direction of Head of QA, support Due Diligence and ad hoc requests, as needed.
Experience & knowledge
- Excellent understanding of quality management systems (QMS) and standards.
- Experience utilizing metrics, KPIs, and QTLs to assess risks to QMS and QA processes.
- Knowledge of Good Documentation Practices (GDP), leading to compliance with regulatory requirements.
- Work collaboratively with cross-functional teams.
- Worked within Quality Assurance in a similar industry for at least 2 years.
- Excellent proven written and oral communication skills.
- Experience with Microsoft Office at an intermediate level (i.e. Word, Excel, PowerPoint Outlook)
- Previous experience working in clinical research, biotechnology, or pharmaceutical industry.
Preferred Experience & knowledge
- Experience with GxPs (GCP, GMP and GLP an advantage).
- Knowledge of the Industry/Clinical trial process and drug development.
Education & qualifications
BS with at least 2 years’ experience with QMS within pharmaceutical and/or biotech industry or equivalent combination of education and experience.