Head of Quality Control

Application Deadline:
30 November 2025

Department:
S-MIC Quality

Location:
Stevenage (SMIC)

Description
The 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 Responsibilities
QC Laboratory Governance:

The Head of Quality Control reports directly to the Director of Quality and is responsible for the strategic leadership and operational management of the Quality Control department. Encompassing both analytical and microbiology functions, the Head of Quality Control will ensure delivery of accurate, timely, and compliant testing for collaborations in support of raw materials, in-process checks, and final product release.

Responsibilities include:

• Working within a multi-disciplinary leadership team to lead and oversee the quality control department within and a MHRA licensed GMP facility ensuring that the laboratory facilities are inspection ready and compliant at all times
• Leading on the Quality Control/Analytical oversight of collaborator process and method transfers
• Taking a lead role for quality across both MICs, working closely with the Head of Quality Assurance
• Ensuring the laboratory procedures and processes are fit for purpose
• Ensuring transfer of robust methods between laboratories according to regulatory requirements
• Ensuring the selection, purchasing, validation of the laboratory facilities and equipment
• Facilitate the escalation of compliance issues to the Head of Quality Assurance and Quality Director
• Ensuring the management of QC Laboratory related Metrics
• Supporting the Quality Director in Managing Regulatory Agency Inspections/third party audits
• Undertaking regular performance reviews for direct reports
• Working with other CGT Catapult QC Leads to develop skills, systems, and processes in line with industry best practices
• Supporting project delivery and project management
• Oversight of QC laboratory work scheduling and resource allocation ensuring its efficient operation
• Managing the provision of technical training and coaching to the Quality Control group
• Involvement/oversight (as appropriate) in the recruitment of new employees as the group's capability expands
• Reviewing current service provisions and ensuring they are fit for purpose from a quality and regulatory perspective and are of a high standard for Collaborators
• Ensuring a high standard of GDP compliance with all documentation being comprehensive and suitable for use
• Managing reviewing, writing, and approving documentation in line with QHS&E standards
• Overseeing the progression of QC owned non-conformances, change controls, CAPA's, 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 business
• Ensuring the QC function operates to a high standard and complies with cGMP and other appropriate regulatory standards
• Providing 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 standard
• Ensuring 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 activities
• Oversee 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 conclusion

The 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.

Experience:

• Appropriate managerial experience in QC within a GMP licensed aseptic (bio)pharmaceutical manufacturing environment
• Experience 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 documents
• Proven experience of looking critically at own and others work practices and procedures and identifying and implementing any needed improvements
• Proven experience of motivating teams, whilst training and acting as a role model for employees associated with the GMP QC laboratories
• Experience in interacting with the regulatory authorities
• Experience in interacting with Collaborators and stakeholders

Skills, Knowledge and Expertise

• Highly 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 UK
• Desire 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 success
• Excellent interpersonal, communication (oral and written) skills
• Expertise in the application of EU GMP to QC operations
• Expertise in pharmaceutical microbiology
• Able to evaluate complex situations and find solutions for them in a professional manner
• Project ownership and pride in its delivery
• Having a passion for delivering excellent customer service in a cost effective way
• Ambitious, collaborative, driven
• Resilient, with the ability to manage multiple and varied tasks and prioritise workload within a fast-paced professional environment
• Flexible and pragmatic, able to learn quickly and respond flexibly to project needs and priorities
• Flexibility towards work assignments with the ability to manage multiple and varied tasks, and to prioritise workload with accuracy and a strong attention to detail
• Comfortable operating autonomously once goals and objectives are set
• A good team player with a hands-on approach, and adaptable to new challenges
• Ability 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 needs
• Proven diplomacy skills with diverse groups of internal and external stakeholders
• A positive attitude towards learning, personal and professional development
• Keeps up to date with professional knowledge, expertise, and best practice
• Willingness to travel

Education / Qualifications:

• Bachelor's degree in Microbiology, Biotechnology, Molecular Biology, or related discipline
• Member 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. In 2024, we received bronze accreditation from Inclusive Employers.