CMC, Manufacturing and Testing

• Provide QA oversight and guidance for CMC development and outsourced manufacturing and testing.
• Review and approve relevant CMC, manufacturing, testing and quality documentation.
• Ensure external partners conduct GMP activities under appropriate quality controls.
• Identify, assess and escalate quality risks, and ensure quality requirements are reflected in development and manufacturing plans.

Clinical Supply

• Oversee clinical trial material supply throughout development.
• Ensure appropriate GMP and GDP oversight of manufacture, packaging, labelling, testing, release, storage and distribution.
• Oversee clinical supply vendors and investigate quality events, including deviations, temperature excursions, complaints and returns.
• Provide QA input to clinical supply planning and risk management to support timely, compliant supply.

Quality Events and Risk Management

• Oversee deviations, investigations, CAPAs and change controls for internal and outsourced activities.
• Ensure quality events are assessed, documented, escalated and closed promptly.
• Support quality-by-design and risk-proportionate approaches that are consistent with ICH GCP (E6(R3)) principles.
• Lead or support root-cause analyses and quality risk assessments, and ensure effective corrective, preventive and risk-mitigation actions.
• Monitor trends and communicate significant or emerging risks through appropriate governance channels.

Inspection Readiness and Regulatory Support

• Lead and support preparation for GCP inspections conducted by regulatory authorities, including sponsor inspections, investigator site inspections and service-provider inspections.
• Coordinate ongoing inspection readiness across clinical programmes, internal functions, external partners and clinical service providers.
• Review regulatory documentation and submissions for consistency, accuracy, data integrity and compliance with applicable GxP and regulatory requirements.
• Maintain quality systems, documentation, records and governance arrangements that support inspections.
• Plan readiness assessments and mock inspections, and support or lead audits and regulatory inspections.
• Coordinate inspection-related responses, commitments and CAPAs through effective closure.

Cross-Functional Leadership

• Act as a trusted QA partner to CMC, Clinical, Regulatory and other functions.
• Provide clear, pragmatic, risk-based advice and embed quality requirements in project and development plans.
• Communicate significant quality risks, issues and trends through appropriate governance forums.
• Contribute to quality strategy and collaborate with other QA leads to maintain an integrated approach.
• Strengthen the Company’s quality culture as its clinical pipeline advances.

Qualifications

Essential:

• An undergraduate degree in a relevant scientific or technical discipline, such as pharmacy, pharmaceutical sciences, biology, biochemistry, biotechnology, chemistry or a related life science.
• Extensive practical knowledge of GMP and GDP requirements, with demonstrable QA experience across pharmaceutical development, CMC, manufacturing, testing and clinical supply operations in a GxP environment.
• Demonstrable experience providing quality oversight of clinical development activities in accordance with ICH Good Clinical Practice (ICH E6(R3)), including CRO/vendor oversight, quality risk management, CAPAs and inspection readiness, while ensuring the protection of trial participants and the reliability of clinical trial data.
• Experience providing QA review and oversight of regulatory documentation and submissions, ensuring compliance with applicable GCP, GMP, GDP and regulatory requirements.
• Proven experience working within an outsourced development and manufacturing model, including oversight of CMOs/CDMOs, CROs, testing laboratories and other GxP-critical suppliers.
• Demonstrable experience in QA oversight of CMC, manufacturing and testing activities, preferably within an R&D or clinical-stage biotech environment.
• Experience establishing, reviewing, negotiating and maintaining quality agreements with external partners.
• Demonstrable experience planning and leading GMP/GDP vendor audits, including assessing findings and overseeing CAPAs and follow-up actions.
• Strong experience managing deviations, investigations, CAPAs, change controls and quality risk management.
• Experience providing QA oversight of clinical trial supply, including relevant GMP/GDP requirements for manufacture, testing, release, packaging, labelling, storage and distribution.
• Experience supporting regulatory inspection readiness and regulatory inspections, including preparation, response and follow-up.
• Experience developing, implementing and continuously improving QMS processes, procedures and systems within a growing organisation.
• Demonstrable ability to provide pragmatic, risk-based QA advice and work effectively with cross-functional teams.
• Strong communication, influencing and stakeholder management skills, with the ability to build effective relationships with external partners and internal stakeholders.

Desirable:

• Experience helping a small or mid-sized biotechnology company to build a mature QMS during its transition to late-phase clinical development.
• A formal quality or auditing qualification.

The above statements reflect the general tasks, duties, activities and/or responsibilities necessary to describe this position and is not intended to set forth all of the specific requirements of the job. These job duties/responsibilities may change or vary in response to changing business needs.

Further details about Scancell may be found at: www.scancell.co.uk.

If you would like to be considered, please send a full CV and a covering letter specifying the position and location you are applying for, and how your particular skills and experience are relevant for this post to: jobs@scancell.co.uk

Salary: Competitive salary and comprehensive employee benefits

Closing date: 22 September 2026