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Summary
I am recruiting for an AI-driven biotechnology company developing technologies that transform clinical development and healthcare.
I am seeking a hands-on QA/GxP Lead with strong expertise across GCP, GMP and computerised systems validation (CSV) to provide quality leadership for a late-stage gene therapy programme. You will own the day-to-day GxP quality framework, ensuring compliance, inspection readiness and effective oversight across clinical, manufacturing and technology activities.
This role offers significant ownership, with the opportunity to shape quality systems from an early stage while supporting a Phase III ATMP programme, external partners, and emerging AI-enabled clinical development tools.
Responsibilities
- Lead sponsor-side GCP quality oversight for a late-stage clinical development programme, ensuring compliance with applicable regulatory requirements including ICH GCP, FDA regulations, EU Clinical Trials Regulation and UK clinical trial legislation.
- Maintain and improve a risk-based GxP quality management system covering clinical operations, CROs, investigator sites, laboratories and other external partners.
- Develop and manage quality oversight activities, including quality agreements, audit plans, key quality indicators, risk assessments and issue escalation processes.
- Oversee deviations, CAPAs and quality events, ensuring timely investigation, resolution and continuous improvement across the programme.
- Provide quality input into clinical development activities, ensuring processes are inspection-ready and aligned with regulatory expectations.
- Support oversight of external manufacturing partners, including GMP quality activities, change controls, product specifications and the GMP–GCP interface for investigational products.
- Ensure appropriate quality oversight of product handling, storage, shipment, traceability and accountability requirements.
- Support regulatory inspection readiness activities, including preparation for inspections, partner audits and responses to regulatory queries.
- Provide quality oversight of computerised systems and technology-enabled processes, ensuring appropriate validation, data integrity and compliance with applicable GxP requirements.
- Apply knowledge of CSV principles, GAMP 5, electronic records requirements and data integrity expectations to regulated systems and emerging technologies.
- Partner with cross-functional teams to embed practical, scalable quality processes within a growing organisation.
- Identify opportunities to improve quality systems, processes and ways of working while maintaining a strong focus on compliance and operational delivery.
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Requirements
- Degree in Life Sciences, Pharmacy, Engineering, Quality Assurance or a related scientific discipline.
- 10+ years’ experience in GxP Quality Assurance within biotechnology, pharmaceutical, CRO or clinical development environments.
- Strong knowledge of GCP requirements and experience supporting late-stage clinical trials.
- Experience managing quality oversight of outsourced partners, including CROs, vendors and external service providers.
- Good understanding of the GMP–GCP interface for investigational medicinal products.
- Experience managing quality systems, deviations, CAPAs, audits and inspection readiness activities.
- Comfortable working independently in a fast-paced environment and influencing teams without direct authority.
- Strong attention to detail with a pragmatic, solutions-focused approach to quality and compliance.
- Experience supporting regulatory inspections or sponsor audit activities is highly desirable.
- Exposure to complex biological therapies, including cell or gene therapy, is advantageous.
- Knowledge of computerised systems validation, GAMP 5, electronic records and data integrity principles is preferred.
- Familiarity with eQMS platforms and quality improvement methodologies is beneficial.
- Interest in emerging technologies and their application within regulated healthcare environments.
- Excellent communication skills with the ability to work effectively across technical, clinical and operational teams.
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