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 utilize his/her experience, understanding of GxP, 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.
- Support the review of quality issues and collaborate cross-functionally to ensure risk-based solutions are implemented in a timely manner.
- Collaborate with stakeholders to support ongoing risk assessments of functional activities and be a point person to assist in determining appropriate escalation, along with timing.
- Provide regular updates on significant compliance issues or trends to the Head of Quality and/or other Functional Heads to ensure risk-based solutions are implemented in a timely fashion.
- Work with functions toward solutions to ensure continuous improvements to embed quality as a hallmark in everything we do.
- Provide input on next generation eQMS and electronic systems capabilities (i.e. new systems, technologies, and/or efficiencies that enhance the effectiveness of compliant clinical trial execution and/or product development initiatives).
- Provide support and guidance during and following internal audits and external regulatory inspections (as required).
- Support the review of Quality Issues (QIs), CAPA proposal(s) from audit findings, and internal audit findings, as needed.
- Author, facilitate review, and obtain approval for best practice documents, standard operating procedures, and templates while ensuring consistency with GxP and regulatory requirements.
- Plan, build, and facilitate trainings, as needed.
- Work closely with QMS administrators and/or QA team members to prioritize and communicate release dates for SOPs/procedures across organization.
- Assist in the creation and maintenance of effectiveness checks for CAPAs, as applicable.
- Support IT department to assess, test and manage eQMS.
- Lead QA operational meetings to discuss status of audits, planned audits, and CAPA extensions.
- Support issuance and review of metrics as part of quarterly QMS review meeting.
- Attend and contribute to action items identified as part of weekly Quality Monitoring meetings.
Experience & knowledge
- Excellent understanding of quality management systems (QMS).
- Experience utilizing QMS metrics, KPIs, and QTLs to assess risks to clinical research and drug development processes.
- Working knowledge of “good practices” (GxP), leading to compliance with regulatory requirements.
- Previous experience working in clinical research, biotechnology, or pharmaceutical industry.
- Knowledge of the Industry manufacturing process and drug development.
- Knowledge of the manufacture of sterile injectable T cell antigen receptor-based therapeutics produced in bacterial cell culture.
- Work collaboratively with existing teams.
- Able to foster support and influence stakeholders throughout the company.
- Excellent proven written and oral communication skills.
- Experience with Microsoft Office at an intermediate level (i.e. Word, Excel, PowerPoint Outlook)
Preferred Experience & knowledge
- Previous experience of managing quality systems in the pharmaceutical or Biotech industry
- Knowledge of GCP and GLP
- Knowledge of the Industry/Clinical trial process and drug development
Education & qualifications
BS with at least 5-10 years’ experience with QMS and working within Quality Assurance within pharmaceutical and/or biotech industry