Head of Quality Control

Head of Quality ControlSkills, Experience, Qualifications, If you have the right match for this opportunity, then make sure to apply today.Join to apply for the Head of Quality Control role at Cell and Gene Therapy Catapult.Application Deadline: 30 November 2025Department: S-MIC QualityLocation: Stevenage (SMIC)DescriptionThe Head of Quality Control will take day‑to‑day responsibility for the microbiological and analytical laboratories at the CGT Catapult Manufacturing Innovation Centre’s (MICs) in Stevenage and Braintree. Both MICs are MHRA licensed facilities, designed to allow collaborating resident organisations ("Collaborators") to manufacture advanced therapy medicinal products in their own, dedicated cleanroom(s). The Head of Quality Control is pivotal in ensuring that both facility’s QC laboratories and the services they provide meet the standards and expectations of the regulatory authorities and Collaborators. As part of the CGT Catapult MIC leadership team, the Head of Quality Control will ensure that current and future needs of Collaborators are met and aligned with their phase of clinical development. This role comprises membership of the MIC Leadership Team (LT) and requires strong cross‑functional engagement with stakeholders across CGT Catapult to ensure the QC department is delivering enhanced support for Collaborator manufacturing and testing capability.Key ResponsibilitiesWorking within a multi‑disciplinary leadership team to lead and oversee the quality control department within an MHRA licensed GMP facility ensuring that the laboratory facilities are inspection ready and compliant at all timesLeading on the Quality Control/Analytical oversight of collaborator process and method transfersTaking a lead role for quality across both MICs, working closely with the Head of Quality AssuranceEnsuring the laboratory procedures and processes are fit for purposeEnsuring transfer of robust methods between laboratories according to regulatory requirementsEnsuring the selection, purchasing, validation of the laboratory facilities and equipmentFacilitate the escalation of compliance issues to the Head of Quality Assurance and Quality DirectorEnsuring the management of QC Laboratory related MetricsSupporting the Quality Director in Managing Regulatory Agency Inspections/third party auditsUndertaking regular performance reviews for direct reportsWorking with other CGT Catapult QC Leads to develop skills, systems, and processes in line with industry best practicesSupporting project delivery and project managementOversight of QC laboratory work scheduling and resource allocation ensuring its efficient operationManaging the provision of technical training and coaching to the Quality Control groupInvolvement/oversight (as appropriate) in the recruitment of new employees as the group’s capability expandsReviewing current service provisions and ensuring they are fit for purpose from a quality and regulatory perspective and are of a high standard for CollaboratorsEnsuring a high standard of GDP compliance with all documentation being comprehensive and suitable for useManaging reviewing, writing, and approving documentation in line with QHS&E standardsOverseeing the progression of QC owned non‑conformances, change controls, CAPAs, internal audit actions and Impact assessments throughout their lifecycle.Building excellent working relationships with QA and developing an acute understanding of the quality‑risk appetite within QA and the wider businessEnsuring the QC function operates to a high standard and complies with cGMP and other appropriate regulatory standardsProviding oversight to ensure all QC laboratory equipment is maintained fit for purpose (qualified and calibrated appropriately)Reviewing and approving cGMP documentation such as Standard Operating Procedures, Analytical Test Methods, Analytical Test Qualification protocols, and reports etc.Ensuring the CGT Catapult QC group and associated service providers complete all documentation and records accurately, contemporaneously and to a consistent GMP standardEnsuring systems are in place and being followed such that the traceability of all reagents, materials, equipment, standards etc. are maintained for all GMP sampling and testing activitiesOversee major Out of Trend & Out of Specification events associated with QC activity and act as Collaborator liaison to report and manage such events to an appropriate and compliant conclusionThe Head of Quality Control may be required to undertake other duties as reasonably required as the CGT Catapult MICs evolve under the dynamic CGT Catapult business strategy.In addition to the above, the Head of Quality Control will be expected, on a rotational basis, to perform the role of the ‘On Call Duty Manager’; to manage and co‑ordinate operational incidents and emergencies across CGT Catapult and Collaborator teams that take place at the CGT Catapult MICs outside of core working hours.ExperienceAppropriate managerial experience in QC within a GMP licensed aseptic (bio)pharmaceutical manufacturing environmentExperience of Advanced Therapy Medicinal Products (ATMPs) in relation to QC testing for early and late‑stage clinical trials (desirable)Proven experience of writing and reviewing GMP documentsProven experience of looking critically at own and others work practices and procedures and identifying and implementing any needed improvementsProven experience of motivating teams, whilst training and acting as a role model for employees associated with the GMP QC laboratoriesExperience in interacting with the regulatory authoritiesExperience in interacting with Collaborators and stakeholdersSkills, Knowledge and ExpertiseHighly motivated, pragmatic, and practical to support the mission of the CGT Catapult to assist in the acceleration of the development of a commercial cell and gene‑based therapy industry in the UKDesire to establish a high profile career within the cell and gene sector and the personal drive to help push the sector to be a commercial successExcellent interpersonal, communication (oral and written) skillsExpertise in the application of EU GMP to QC operationsExpertise in pharmaceutical microbiologyAble to evaluate complex situations and find solutions for them in a professional mannerProject ownership and pride in its deliveryHaving a passion for delivering excellent customer service in a cost effective wayAmbitious, collaborative, drivenResilient, with the ability to manage multiple and varied tasks and prioritise workload within a fast‑paced professional environmentFlexible and pragmatic, able to learn quickly and respond flexibly to project needs and prioritiesFlexibility towards work assignments with the ability to manage multiple and varied tasks, and to prioritise workload with accuracy and a strong attention to detailComfortable operating autonomously once goals and objectives are setA good team player with a hands‑on approach, and adaptable to new challengesAbility to quickly establish credibility and build rapport and trust Proven ability to engage constructively with colleagues at all levels across different departments to deliver objectives and to respond to a wide range of customer and management needsProven diplomacy skills with diverse groups of internal and external stakeholdersA positive attitude towards learning, personal and professional developmentKeeps up to date with professional knowledge, expertise, and best practiceWillingness to travelEducation / QualificationsBachelor’s degree in Microbiology, Biotechnology, Molecular Biology, or related disciplineMember of a recognised professional body (Desirable)CGT Catapult is committed to providing an equal, diverse, and inclusive work environment where everyone’s contributions are valued. We celebrate differences, empower, and inspire everyone, because when everyone is included, everyone wins. xpwpeyx In 2024, we received bronze accreditation from Inclusive Employers.Seniority levelDirectorEmployment typeFull‑timeJob functionQuality Assurance#J-18808-Ljbffr