Quality Manager (GCP)
(USA: Rockville, MD or Conshohocken, PA)
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 Quality Manager- GCP role will provide support and lead the execution of clinical Quality Assurance activities within the company, overseeing clinical activities relating to the Quality Management System, and working closely with internal colleagues to develop systems and processes in-line with regulatory requirements, GCP and internal quality processes, as applicable.
- Support Head of QA to oversee the Quality Management System for GCP.
- Assist in managing core clinical and QA processes including being owner for some agreed QMS processes, as applicable.
- Perform internal and external audits for clinical activities as defined by the Internal Audit Schedule and as needed.
- Perform external vendor/ supplier audits for clinical activities as defined in Audit Schedule and as needed.
- Assist in other internal audits and external audits, as required.
- Prepare audit plans, perform and report audit findings to the auditee, Head of Functional area and Head of QA.
- Evaluate and provide oversight for potential risks, standards and quality principles.
- Support Inspection Management Team in preparation for and management of regulatory authority inspections
- Assist in establishing processes to ensure Data Integrity and communicate the principles of data integrity for GCP.
- Facilitate the development, monitoring, and continuous improvement of CAPAs / risk mitigation plans and effectiveness checks.
- Give consultative assistance to Head of QA and Functional area(s) in relation to clinical QA / risk questions/issues.
- Maintain an up to date knowledge and log of applicable legislation and regulatory guidelines.
- Provide in-depth quality reviews of data and documentation, as required.
- Lead or 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 training/mentoring on clinical QA as required.
Experience & Knowledge
- Established GCP / QA professional
- Excellent knowledge of GCP and GCLP (GPvP and GMP an advantage)
- Strong understanding of quality management systems and (GxP), to ensure compliance with regulatory requirements
- Knowledge of corporate governance, health care regulations, laws and standards
- Strong collaborative, partnering, and interpersonal skills
- Previous experience working in Clinical Research, Biotechnology or the Pharmaceutical Industry and knowledge of the Industry drug development process.
- Excellent analytical, written and oral communications skills
- Able to foster support and influence all stakeholders throughout the company
- Worked with Microsoft Office at an intermediate level (i.e. Word, Excel, PowerPoint Outlook)
- Worked within Quality Assurance in a similar industry for at least 5 years
- Previous experience managing quality systems in the pharmaceutical or Biotech industry
- Strong ability to work independently
- High ethical standards, trustworthy, operating with absolute discretion
Education & Qualification
- A degree or higher degree in a relevant subject
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.