QA Manager Cell Therapy GMP Quality

Job Description

Do you have a passion for Quality and a background within Pharmaceutical or Biologics environments, regulated to GMP (and ideally HTA/ISO) standards If so, this is a unique opportunity for an ambitious, positive-minded individual, to join a fast-growing cell therapy organisation in Cambridge, which is going to be applying for an HTA licence and will then be implementing a brand-new electronic QMS later in the year. This is a newly-created permanent role for a QA Manager. You will lead, mentor and grow a team (currently 3 people, with more to join in 2021) and will have a range of duties to provide Quality and Compliance support to all departments and drive continuous improvement. We are looking for an energetic, collaborative, honest and versatile person to join a pioneering company at the forefront of synthetic and stem cell biology, manufacturing human cells for research and drug discovery purposes. This is a permanent position, paying a very generous salary, to discuss on application. You will be officially based in the company’s modern site in Cambridge, though for time being this role is home-based. You will therefore need to live within commutable distance of Cambridge or be prepared to move to the area in due course.Reporting to the Head of QA, your role will include: - Leading a bright and hard-working team (currently 2 QA Officers and a Document Control Specialist, with more people to join)- Developing, implementing and maintaining Quality System processes and procedures at the Cambridge site including CAPA, risk management, non-conformances, change control and validation to ensure compliance with internal standards and relevant regulatory requirements.- Providing leadership and support in the management and control of QMS documents and records to ensure preparation, control, review and approval is performed on a timely basis.- Scheduling, planning and performing internal audits in accordance with an approved schedule, and progressing and monitoring corrective actions.- Scheduling, planning and performing due diligence and routine surveillance audits of third party contractors and suppliers to ensure compliance with company and regulatory compliance.- Acting as principal QA contact, in liaison with relevant departments, in the handling, reporting of quality issues which arise in the manufacture, testing, packaging and supply of materials or product (both internally and through external parties).- Developing, implement and maintain an effective system for handling quality complaints and establish effective feedback mechanisms to determine whether the organisation meets customer requirements.- Provide quality representation at all Quality review meetings at local and site level.- Developing, facilitating and maintaining a training matrix and GMP / Quality-related training programmes- Hosting customer audits and participating in regulatory site inspections.- Supporting development of personnel by providing relevant training, tools, skills and motivation to provide opportunities for personal improvement and encourage contribution towards continual improvement.Benefits:In addition to a generous basic salary, the company offers the following benefits package:- 30 days holiday- 5% match contributory pension - after three months- Private healthcare - with Vitality (the highest level of cover you can get) after three months- Life assurance- Cycle to work scheme- Electric car scheme - coming in soonSkills and Experience Required:- Strong experience of Quality Assurance gained within a commercial Pharmaceutical setting, ideally in a Biologics, Cell Therapy / ATMP or Biopharmaceutical organisation, regulated to GMP and HTA standards- Understanding of Continuous Improvement Tools e.g. LEAN, 5S, Kanban, Kaizen, RCA, VSM.- Experience of implementing / working with an eQMS processes (e.g. Trackwise, MasterControl, Q-Pulse)- QESH Management System / ISO9001 / PDCA Training preferred- Life science qualification helpful but not essential- Excellent communication skills and ability to work with people at all levels- Proactive, driven, pragmatic, open-minded, emotionally intelligent, positive and respectful approach to your workFull details will be provided on application. This is a permanent role in Cambridge, Cambridgeshire, but will be home-based to begin with.