Head of Quality Operations

BaseBio; Cambridge; On-site; GBP 70,000 - 90,000; Full time

Job summary

A leading biotech company in the UK seeks a Head of Quality Operations to ensure compliance with EU and FDA regulations in manufacturing and testing activities. You'll lead a dynamic team, support client interactions, and drive continuous quality improvements. Ideal candidates will have a scientific degree, over 5 years of quality leadership experience, and strong analytical skills. Join a growing organization committed to transformative science and make an impact in cell and gene therapy.

Benefits

Collaborative work environment

Opportunities for professional development

Qualifications

• A minimum of 5 years of experience in Quality Leadership roles.
• Proven ability to lead, mentor, develop, and motivate a Quality team.
• Experience with CMC, process development, and technical transfer.
• Knowledge of relevant regulatory standards and excellent problem-solving skills.

Responsibilities

• Lead the Quality Operations Team, overseeing batch review and release activities.
• Ensure compliance with EU and FDA requirements.
• Develop and maintain Quality Management System processes.
• Support onboarding of clients and regulatory interactions.

Skills

Leadership

Quality Management

Analytical Skills

Communication

Regulatory Knowledge

Education

Bachelor’s degree in a scientific discipline

Tools

Quality management software

Job description

4basebio is at the forefront of one of the most transformative areas in biotechnology: Cell and Gene Therapy (CGT). Our mission is to enable the next generation of life‑saving genetic medicines through the manufacture and supply of premium quality synthetic DNA, produced via a proprietary, enzymatic, cell‑free process. Unlike traditional plasmid‑based methods, our platform delivers greater safety, speed, and scalability, unlocking critical efficiencies for CGT innovators.

As a trusted CDMO partner to leading biotech and pharmaceutical companies, we empower breakthroughs in cell and gene therapy, mRNA vaccines, gene editing, and other advanced modalities. At 4basebio, you’ll be part of a company where cutting‑edge science translates into real‑world impact, transforming patient outcomes and shaping the future of medicine.

Job Purpose:

The Head of Quality Operations will report to the VP of Quality and responsible for ensuring the manufacturing activities and testing activities in place at 4basebio remain in the validated state and comply with EU and FDA requirements in terms of legislation and guidance and adopting a risk‑based approach.

This is an externally facing role, with regular contact with clients (pre/post sale) with respect to GMP and quality matters and will provide support on regulatory interactions for clients as and when required.

Facilitate technical transfer of manufacturing processes from PD & MS&T providing Quality oversight to ensure smooth and timely transfers take place.

Contribute towards corporate quality initiatives to improve the Quality Programs, ensuring the elements of the QMS in regard manufacture, testing and release activities meets regulatory requirements in terms of performance.

Deputise for the Director, Quality Operations in Quality Operations matters.

Responsibilities:

• Forms part of the Quality Leadership Team, providing leadership to the Quality Operations Team (GMP oversight manufacturing and testing, batch review and release activities, supplier management and validation management).
• Line Manager for Validation Manager (overseeing qualification and validation and data integrity) and Line manager for QA Manager (overseeing suppler management and batch release).
• Help in the design, implementation and ongoing maintenance of a progression scheme within the Quality Group.
• Regulatory intelligence oversight, evaluation of emerging changes in regulations and legislation and ensuring implementation where 4basebio is impacted by the change in a timely manner.
• Contribute toward the build of Quality Improvement Plans (QIPs), tracking and driving actions to completion.
• Involved with onboarding of clients, support client meetings and be delegate for Director of Quality Operations. Point of contact with clients (pre/post sale) with respect to GMP and quality matters. Provide regulatory support for clients as and when required. Includes Statement of Works (SoW) oversight.
• Support with hosting technical visits, client audits and regulatory inspections ensuring the timely delivery of requested information into the audit room through coordinated efforts of the audit backroom team.
• Oversee the contamination control strategy implementation and evaluate effectiveness periodically.
• Oversee the Product Specification File (PSF) for the batch, ensuring records are up to date, and true copy scans of completed records are uploaded in a timely manner to the electronic folder.
• Maintain product & process knowledge, Post marketing commitments, API register via MHRA portal, Transportation risk assessments Engineering runs/pilot batches.
• Packaging of CSM & DS, labelling policy, product specifications, sampling methods (manual sampling using syringes)
• Environmental monitoring oversight, review of EM quarterly trend reporting, factory isolates, library, EM excursions and alerts.
• Lead the Quality Operations team in the design, implementation, monitoring, evaluation and ongoing management of SOPs and associated documents concerning quality operations. Ensure compliance with the Quality Policy, relevant SOPs, and associated documents concerning quality operations.
• Approve a range of quality documents or delegate these approvals to suitably qualified members of the Quality group.
• Responsible for ensuring a process is in place for escalating critical quality matters to the leadership team promptly.
• GMP champion regarding Quality Operations, promoting use of Quality Management tools (e.g. pareto analysis) and key performance indicators coordinating and promoting best practice across 4basebio.
• Root cause analysis champion for Quality Events including customer complaints. Support troubleshooting particularly for critical deviating events.
• Drive continuous monitoring of the QMS under control of Quality Operations, ensuring compliance with GMP and regulatory requirements. Drive continuous improvement initiatives.
• Delegated chair of the Quality Management Review meeting in absence of Director, Quality Operations. Assist with taking minutes at the QMR meeting.
• Responsible for the in‑take and assessment of incoming complaints and escalate potential recalls to the Leadership team. Ensure complaints are investigated in a timely manner ensuring effective CAPAs are raised and implemented as required. Form part of the recall assessment team as and when required.
• Audit of processes and procedures as and when required to ensure compliance with regulatory requirements and industry best practices.
• Regulatory matters – support preparation of interim compliance reports Decentralised manufacturing (SI 2025/87), support IMPD build/DMF build.
• Lead on the evaluation of incoming regulatory intelligence, where impact to 4bb is determined, ensure changes are implemented in a timely manner to ensure ongoing compliance with regulatory requirements.
• Responsible for ensuring there is sufficient resource for the management of Supplier at 4basebio, being the point of escalation for Supplier related Quality Events and/or concerns.
• Supplier risk assessments, QTA between 4bb and 4bb discovery (Norman Way and Spain), Supplier Questionnaires, Supplier management, supplier notifications, Materials review board, Raw materials and consumable items release, QTAs and outsourced activities, Supply chain maps. BSE/TSE assessments, excipient risk assessments
• Identification of Quality resource requirements to ensure timely delivery of a compliant QMS. Setting work plans, and objective setting for their ongoing development.
• Responsible for ensuring there is sufficient resource for the management of Validation Activities at 4basebio, being the point of escalation for validation discrepancies.
• Drive quality‑related projects and initiatives to support organizational goals.
• Undertake any other appropriate roles and responsibilities that reasonably fall within the role holders’ skills and experience as requested.

Person Specification:

• A bachelor’s degree in a scientific discipline,
• A minimum of 5 years of experience in Quality Leadership roles. Proven ability to lead, mentor, develop and motivate a Quality team, executing deliverables within budget and to timescale.
• Experience with CMC (a critical process in the pharmaceutical industry for developing and manufacturing drugs, especially complex therapies like cell and gene therapies (CGT)), process development (PD) & Manufacturing, Science and Technology (MS&T), new product introductions (NPI), technical transfer of manufacturing processes with a bias towards quality considerations, analytical method development, would be an advantage for the role.
• Experience of creating, maintaining and developing Quality Management System processes, associated documents and delivering training to end users.
• Highly motivated self‑starter, with excellent interpersonal skills, and a flexible approach with excellent communication and organisation skills.
• Excellent analytical skills with the ability to interpret complex quality data and metrics.
• A strong team player motivated by what can be achieved through people and requires engaging and motivating all stakeholders in the organisation.
• Knowledge of relevant regulatory standards, excellent problem‑solving skills, with good attention to detail. Proficient in quality management software and tools.
• Ability to work under pressure and meet tight deadlines.
• Extensive experience as a Lead Auditor is preferred, but not essential.
• Ability to foster a culture of Quality throughout the organisation.

Why Join 4basebio?

At 4basebio, you’ll be part of a mission‑driven team united by a passion for innovation and the belief that our work can profoundly impact patient lives. We foster a collaborative, agile, and supportive environment where your contributions are valued and where you’ll have the autonomy and resources to thrive.

We are growing rapidly and invite you to join us at a pivotal time as we reshape the DNA manufacturing landscape for advanced therapies.

If you're a self-starter with deep biotech experience and a passion for transformative science, we’d love to hear from you. Join 4basebio and help accelerate the future of synthetic DNA.