Biotechnology Jobs

• Cambridge
• £80,000 – £100,000 pa
• Senior

Job Title: Senior QA Validation EngineerLocation - Cambridge: On Site (some flex on occasionSalary - £80k - £100k (depending on experience) + up to 10% bonus (company performance dependent) + equityOverviewWe are seeking an experienced Senior QA Validation Engineer to…

• Stevenage
• Lead

Lead the push for an MHRA MIA(IMP) licence at the first site of an automated CDMO for regenerative medicine, establishing and maintaining a scalable PQS and ensuring production complies with quality policies. The role covers audit leadership, inspection readiness, quality strategy with leadership, and preparing for future commercial batch release, working alongside advisors from Catalent and Resilience.

eQMS · MasterControl · Electronic Batch Records +1

• London
• Hybrid
• £63,917 – £118,703 pa
• Director

Acts as a QA liaison between clinical trial teams and third parties, providing expert support through due diligence, qualification, governance and ongoing monitoring. Focuses on technology-enabled vendors such as digital health tools, medical devices and AI, covering risk assessment, audit support, inspection readiness and escalation of quality issues.

DHT · SaMD · SaaS +1

• Leeds
• Director · manages people

Owns product strategy, roadmap and innovation for clinical pharmacology clinics and bioanalytical labs, spanning early-phase platforms like ClinSpark, LIMS/LIS, ELN, instrument connectivity and lab automation. Builds business cases and secures funding, governs a regulated portfolio, and leads multidisciplinary product teams and vendors across distributed sites.

ClinSpark · LIMS · LIS +7

• Stevenage
• On-site
• Entry level

Support GMP compliance in a multi-product cell and gene therapy facility, reviewing batch manufacturing and QC records, managing controlled documentation, and preparing patient-specific labels. Work with cross-functional teams on batch release, quality events and inspection readiness, on a Sunday–Wednesday shift pattern.

• Seqirus USA - NC - Holly Springs
• Lead

Owns quality oversight of external CROs, laboratories and test facilities supporting nonclinical and GLP activities, running the full vendor lifecycle from due diligence and quality agreements to risk-based monitoring, CAPAs and governance forums. Coordinates inspection readiness and audit support, ensures compliance with GLP/GCP/GMP, OECD GLP, 21 CFR Part 58 and ALCOA+ data integrity, and leads vendor risk assessments such as FMEA and risk registers.

OECD GLP · 21 CFR Part 58 · Annex 11 +3

• Maidenhead
• Lead

Owns quality oversight of external CROs, laboratories and test facilities supporting nonclinical and GLP activities, running the vendor lifecycle from due diligence and quality agreements to risk-based monitoring, CAPAs and inspection readiness. Ensures adherence to GLP/GCP/GMP, OECD GLP, 21 CFR Part 58 and data integrity (ALCOA+), partnering with Nonclinical Development, Procurement, Legal and IT.

OECD GLP · 21 CFR Part 58 · Annex 11 +3

• Leeds
• Director · manages people

Executive leadership role owning QA and regulatory compliance for the Clinical Pharmacology Services unit, covering CPU operations, GMP pharmacy activities and Phase IB/IIA early-phase trials. Sets risk-based quality strategy, inspection readiness and audit programs, leads global matrixed QA teams and represents the company externally on GCP/GMP matters.

• Oxford
• On-site
• Senior

Hands-on sole contributor owning equipment uptime and reliability in a new GMP manufacturing facility, acting as technical escalation point for technicians and contractors. Leads structured troubleshooting, RCA, CAPA ownership, CMMS data integrity, preventative maintenance planning and small capital projects, working closely with Engineering and QA. Supports 24/7 operations across early, mid and occasional night shifts with callouts, applying Lean/6S, RCM, FMEA and digital-first approaches.

CMMS · Maximo · SAP PM +5

• United Kingdom
• Remote
• Senior
• Permanent

Provides clinical quality oversight and a single point of Quality contact for client study teams, partnering with Clinical Operations and Pharmacovigilance to identify, assess and mitigate risks to participant safety and reporting compliance. Co-chairs Joint Quality Councils, analyses QA metrics and audit/inspection trends, and drives quality risk management across a portfolio. Fully remote role with up to 25% travel.

• Macclesfield
• On-site
• Senior
• Permanent · Shift work

Provides QA leadership and GMP/aseptic expertise for aseptic manufacturing and packaging on a permanent night shift, working a 4-on, 4-off pattern. Advises on cleanroom compliance, deviations, CAPA, change control and product release, and coaches manufacturing staff on contamination control and data integrity within the Process Execution Team.

EU GMP Annex 1 · ICH Q9 · ICH Q10 +2

• Cambridge
• Hybrid · 2 days in office
• £65,000 – £80,000 pa
• Senior
• Permanent

Lead regulatory strategy for a cardiology device company expanding into the US, UK, EU and Middle East, owning FDA, CE and UKCA submissions from Class I to Class II/III. Drive an audit-ready QMS (ISO 13485, 21 CFR Part 820, ISO 14971) and advise senior leadership on regulation, quality and clinical governance, working directly with the FDA, MHRA and notified bodies.

FDA · MHRA · UKCA +2

• Ware
• On-site
• Mid-level

Ensures manufacturing and warehouse operations comply with SOPs, cGMP and UK/EU regulatory requirements, investigating deviations and managing CAPA, complaints and change control. Provides quality oversight of facilities, equipment and personnel, coaching staff and running GEMBA and process confirmation activities at a respiratory inhaler and oral solid dose site.

• Cambridge
• Hybrid
• Senior
• Permanent

Full-stack engineer building customer-facing cloud and instrument software plus internal tools supporting in-house protein screening services. Owns features end to end, from gathering requirements with biologists and stakeholders through technical design, implementation and testing across backend, frontend, dev-ops and QA.

• Stevenage
• Hybrid
• Director · manages people

Accountable for onboarding and ongoing performance management of apheresis and treatment centres supporting clinical and commercial CAR T-cell therapies across the UK and Rest of World. Serves as the technical operations single point of contact, conducting site assessments, training centre staff, supporting quality systems and deviations, and managing process change rollouts. Involves up to 50% travel and possible management of contract employees.

Electronic Data Management Systems