QMS Specialist Cell Therapy GMP Quality

Job Description

Do you have a passion for developing efficient, robust Quality Management Systems Do you have a background within Pharmaceutical or Biologics environments, regulated to GMP (and ideally HTA) standards If so, this is a genuinely unique opportunity for an ambitious, positive-minded individual, to join a fast-growing cell therapy organisation in Cambridge, which is just about to implement a brand-new electronic QMS. We are looking for an energetic, open-minded and versatile individual to join a pioneering company at the forefront of synthetic and stem cell biology, manufacturing human cells for research and drug discovery purposes. The company is expanding its QA department from 2 to 5 people, with further growth next year, and they are looking for a QMS Specialist who can undertake a range of exciting projects. This is a permanent position, paying around £45,000 plus excellent benefits. For the right person, the salary could be a little higher than this too. You will be based in the company’s modern site in Cambridge, though they have a very healthy approach towards the current Covid-19 guidelines and will accommodate you working some portion of the time from home, not just in the short term.Reporting to the Head of QA, your role will include: - Develop systems and establish procedures for documenting and monitoring processes such as non-conformities, change controls, deviations, Root Cause Analysis, CAPAs, internal and external audits, supplier approval, risk assessments, continuous improvement and signature register.- Lead change management such as non-conformities, change controls, deviations and CAPAs.- Ensure that QA documentation and processes are current and in line with the relevant regulatory requirements.- Provide review, approval and QA Technical support to key business partners for the management of quality records e.g. risk assessments, continuous improvement, change controls, non-conformities, deviations, CAPAs, supplier approvals and Root Cause Analysis.- Implement, monitor and provide appropriate KPIs for the QA processes, escalate any trending observed to senior management.- Create, revise and maintain QA standard operating procedures (SOPs) and other documents as required.- Act as QA subject matter expert to support business requirements.- Ensure the internal audits are up to date- Provide direct Quality team support during customer audits and regulatory inspections.- Ensure actions from customer audits and regulatory inspections are tracked, followed up internally and ensure responses are sent out to the customer/or regulatory bodies- Provide direct support for quality-related customer complaint investigations and trending activities and ensure responses are sent to customers- Provide Quality systems and process training across the business.- Manage the archiving of business data, both paper-based and electronic.- Manage the collation of data reporting of the Annual Product Reviews for approval.- Write, review and approve Quality Technical AgreementsBenefits: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 document control and the optimisation of QMS processes, especially if electronic rather than paper-based- QESH Management System / ISO9001 / PDCA Training preferred- Strong proficiency in Word, Excel and PowerPoint- 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, paying around £45,000, though this could be higher (i.e. closer to £50k) depending on experience.