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.
As part of the quality team at Immunocore you will oversee, manage and lead the Quality Assurance Department and take the lead to ensure Immunocore is fully compliant with all appropriate regulatory authorities. You will lead and promote joined up quality thinking and decision making across all internal and external operations and build high performing, motivated and skilled Quality team capable of delivering to the standards required.
This role will take accountability for the UK and US teams. It can be located in Conshohocken, PA, Rockville, MD or Abingdon, UK.
- To promote and embed a culture of Quality Assurance excellence and readiness for inspection throughout Immunocore and its partner organizations.
- To ensure Immunocore, is compliant with all regulatory requirements and legislation
- To ensure all activities, processes and procedures are carried out to the highest quality and accuracy standards and in line with industry standards and compliance guidelines
- To ensure full GXP compliance is delivered and maintained across Immunocore.
- To conduct external audits of existing contract manufacturers and suppliers and conduct vendor assessment/selection for all new manufacturers, suppliers and providers.
- To develop and maintain and champion electronic QMS system to track and store all of the key elements related to QA (training, QE, NC, CAPA, RCA, etc.
- To liaise with the QA team and oversee all aspects of Change Control and deviations from specification and the validation required before changes can be implemented.
- To liaise with the HA where appropriate to ensure that the Company conforms to the requirements of GMP and associated manufacturing
- To coordinate the preparation and hosting of inspections by global Health Authorities
- To provide documented feedback relating to all audits and ensure standards are applied and met with follow up training programs and improvements to QA best practice and process within Immunocore.
- To promote a culture where people are focused on quality, compliance, and inspection readiness by design from the start of any company process and to keep the senior leadership informed of any problems relating to QA issues.
- Significant experience in QA at the global level of a biopharma company
- Able to develop and lead a QA team responsible for ensuring GXP compliance across all functional areas
- 5-10 years of experience providing leadership of an organization in at least one area of GXP.
- Successfully conducted inspections by FDA, MHRA and other Health Authorities (HAs)
- Successfully led organization to resolve findings from inspections by a recognized Heath Authority
- Demonstrated abilities to lead CAPA resolutions across several functional departments.
- Demonstrated abilities to train others on root cause analysis, QE identification and CAPA resolutions.
- Demonstrated ability to identify critical findings from major and minor observations.
Management and Leadership:
- Strong leadership qualities: to embody the culture and values of the business, to be highly effective as a team motivator and coach
- First rate interpersonal skills (both written and verbal): an ability to assertively represent the business at the highest level on the one hand, and to communicate and be approachable to all members of the team on the other
- Resilience: an ability to remain calm and organized under pressure
- Methodical and process orientated
- Detailed approach to planning, execution, detail focused, clear thinker
- Excellent documentation skills
- A strong team player with the ability to respond to others in a supportive and flexible manner
- Continuous Improvement of all Quality operations: an ability to self-audit
- To adhere to the highest levels of integrity, professionally and personally
- Highly commercial/business acumen and sense of urgency
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.