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 Quality Assurance Specialist leads the coordination of activities for the Quality Management System (QMS) and QMS workstream team members to ensure adequate oversight, maintenance, continuous improvement, and general upkeep of the system. The QA Specialist will manage the development and maintenance of metrics for Quality Issues (QIs), Complaints, Non-Conformances, Change Control, CAPAs, RCAs, and KPIs with the goal of ensuring that the system is aligned with requisite QMS standards, GxP requirements, company objectives, and procedures, as applicable. This role will conduct audits and lead QA induction training to the broader organization as needed. The QA Specialist will also serve as the company archivist responsible for long-term storage of GxP documents, files, and related materials.
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.
- Supervise the maintenance, administration, and general upkeep of the QMS.
- Coordinate daily management of the QMS to include QC of QMS documents, as well as issue and track QMS Documents for compliance.
- Coordinate QMS activities to ensure that the system is in a controlled state and is compliant with policies, SOPs, best practices, and requirements for the following, as applicable:
- Coordination of other QMS administrators (no direct reports), but authority to coordinate/delegate and set expectations.
- Training and development to enable specific audits to be performed independently
- Create and distribute GxP staff training files for relevant new joiners.
- Update the training matrix on a regular basis and ensure that training assignments are accurately recorded, up to date, and inspection ready.
- Supervise and provide support to QMS Administrators
- Prepare the QMS Metrics and capture minutes of the monthly QMS Review Meeting.
- Take on responsibility as the Process Owner for Archiving.
- Assist in establishing processes to ensure Data Integrity and communicate the principles of data integrity for GCP.
- Support the development, monitoring, and continuous improvement of CAPAs / risk mitigation plans and effectiveness checks.
- Maintain an up to date knowledge and log of applicable legislation and regulatory guidelines.
- Support the development and/or revision of QA processes and procedures including SOPs and risk assessment tools
- Support driving and embedding a culture of ethics, integrity and Quality by Design.
- Provide backroom QC support during regulatory inspection and external audits.
- At the direction of Head of QA, support Due Diligence and ad hoc requests, as needed
Preferred 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.