Job title: Head of Quality Reporting to: Head of GMP Department: GMP No of Direct reports : 3 Location : Bristol Summary: eXmoor Pharma is the only integrated cell and gene therapy CDMO with over 20 years of consultancy expertise embedded across every stage of the CMC journey — from early-phase strategy to process development, GMP manufacturing and commercialisation. We provide comprehensive support across Viral Vectors, Autologous and Allogeneic Cell Therapies, and RNA technologies. This integrated model enables seamless progression from early-phase strategy through to commercial readiness. The Head of Quality will be responsible for the ongoing management of the GMP Quality team and its continued expansion, and taking a lead role in establishing and operating the GMP PQS and Quality Control department. The Quality function oversees eXmoors PQS and ensures a Quality Culture is embedded into its GMP functions. The Quality team comprises of two main functions, the QA team and the Analytical Services (AS) team, of which the QC function forms a part of. This is an exciting opportunity to work with eXmoor’s globally recognised team of scientists, consultants and engineers. You will work on a wide range of Client projects in a rapidly growing business whilst developing your own quality management career. Job Description: Job Purpose: The GMP manufacturing facility is capable of handling a wide range of cell and gene therapies as well as small scale complex biologics. The Head of Quality will take responsibility for setting the Quality Culture within the GMP operations and report to senior leaders on the companies compliance to Quality standards. A leader with the ability to build and grow the Quality function to meet business needs. The Head of Quality will help further establish and develop the GMP Quality team and will be responsible for the day-to-day management, operation, scheduling and administration of the PQS and QC operations ensuring that they are operated and maintained as required by the facility’s licences. Main areas of responsibility / key duties: You will conduct your duties to the highest quality standard and in a safe way complying with all policies and procedures and with due care and attention for yourself and your peers. You will be responsible for maintaining the PQS and leading the team responsible for the management of the system. You will recruit, train, develop & supervise QA and AS staff to meet planned production/PD needs and departmental budgets and establish a motivated, capable team. You will ensure the QA/AS team are provided with the required training to enable them to perform their jobs and meet the overall teams responsibilities, whilst also supporting their own individual growth and development. You will ensure all aspects of the laboratories (including maintenance, operation, qualification, validation, material storage and waste) are managed in compliance with the facility’s stated policies and procedures. You will lead the implementation of SOPs for all activities within ownership of QA and the AS laboratory function. You will lead AS to ensure analytical results (GMP) are reviewed and approved at an appropriate level before submission to QA for review. You will lead QA to ensure that production/QC records are evaluated and signed by authorised personnel before they are sent to the Qualified Person (QP) for review. You will lead QA to manage the systems that comprise the PQS including, risk management, deviations, change control, self inspections/audits, complaints and recall, and OOS. You will lead QA to review and approve all operational SOPs prior to implementation. You will lead QA to complete routine quality reviews and approval of maintenance, calibration and validation activities, as required. You will lead AS in the reporting on environmental monitoring trends. You will communicate with Qualified Persons any issues impacting on QP responsibilities and batch certification. Along with the Head of Production you will ensure requirements of IMPD are translated into operational activities and specifications. You will ensure the PQS is performing, as measured against set KPIs and to communicate performance with the senior leadership team, escalating issues as required. You will ensure that all AS validations/qualifications are complete and up to date. You will support the AS lead in ensuring the AS function is able to support both QC and AD functions You will control and supervise the system for the management of reference/retain samples of materials and products. You will input into the GMP technical transfer processes for AS You will work in conjunction with the Head of Production to develop, maintain and communicate product specifications, including starting materials, in process testing specifications, intermediates, bulk drug substance and final filled drug product quality control specifications and testing schedules. You will approve sampling plans and specifications. You will host and support the teams during regulatory and client audits You will ensure all required documentation across all GMP operations meets the requirements of Data Integrity and are maintained in line with the manufacturing licences. You will manage all aspects of Quality planning including resource, budget, progress reporting and forecasting. You will work with the Head of Production and eXmoor Procurement team to ensure the procurement and storage of key supplies occurs in line with the production schedule and procurement processes. You will monitor compliance with GMP within Quality. Participate in Management reviews of process performance and product quality. Advocate continuous improvement. Escalate quality issues quickly and effectively to the appropriate management levels. Person Specification: Essential Qualifications & Experience: Education to post graduate degree level in appropriate subject area – MSc or equivalent experience Considerable experience (10 years plus) of managing GMP Quality Systems and teams, and QC operations. In depth understanding of legislative framework of MHRA, HTA and H&SE in Good Manufacturing Practice as applied to small scale biopharmaceutical production for clinical trials. Extensive experience in a supervisory role. This includes the ability to lead, develop, motivate, and organise a small team. Proven experience of managing complex Quality systems and ensuring the implementation of operating procedures and efficient record keeping. In depth understanding and experience of the following processes PQS systems such as deviations, change management, risk management, OOS, audits/self Inspections and product complaints C> analytics related to the assay, purity, identity, safety and potency of drug products Resilience and flexibility; able to communicate the Quality requirements to all levels of the company and lead a team which whilst being Quality focused. Hosted regulatory and client audits Desirable Qualifications & Experience: Qualified Person (QP) In depth understanding and experience of technologies used in the analysis of cell and gene therapy products including FACS, HPLC and PCR Knowledge of Good Laboratory Practice (GLP) and routine in-process and QC assay techniques such as HPLC, PCR, sterility testing, mycoplasma testing, ELISA, SDS PAGE. Qualified Person with experience in the certification of ATMP products Competences Required: Organisation, planning and time management Ability to show pragmatic approach to solve Quality issues Commercially aware and able to manage procurement & budgets. Oral and written communication skills, ensuring clear direction and decision making Leadership and teamworking Attention to detail and ability to complete activities Problem solving Building constructive relationships and earning respect Motivated by growing a bio-technology business in the CGT / biopharmaceutical market Proficiency in Office365 (including Word, Excel, PowerPoint).