Senior Quality Assurance Manager in Oxford

The Senior Quality Assurance (QA) Manager will act as a QA functional lead and key member of the Company's cross-functional development team, providing expert quality leadership across the organisation. Operating within an outsourced development and manufacturing model, the post holder will govern GMP/GDP activities across CMC, manufacturing, testing and clinical supply throughout the development lifecycle.

Working closely with CMC and other internal functions, the post holder will lead and coordinate quality activities across external development, manufacturing, testing and clinical supply partners. Responsibilities will include vendor governance, quality agreements, risk-based audits and the management of deviations, investigations, CAPAs, change controls and quality risks, ensuring appropriate GMP/GDP standards and effective resolution of quality issues.

The post holder will also ensure that clinical development activities comply with ICH Good Clinical Practice (ICH E6(R3)), applicable regulatory requirements and Company procedures, including risk-based quality management, sponsor governance of delegated activities, protection of trial participants and the integrity and reliability of clinical trial data.

The role will cover clinical trial material supply and inspection readiness, including regulatory inspection preparation, responses and follow-up, as appropriate.

The post holder will also contribute to the development and continuous improvement of a robust, proportionate and risk-based quality framework, including internal processes, procedures and systems, to support the evolving needs of the Company's programmes and their progression through clinical development.

Key duties and responsibilities

Quality Management System and Continuous Improvement

• Develop, implement and maintain proportionate, risk-based QA policies, processes, procedures and systems.
• Maintain and continuously improve the QMS as the organisation and its development programmes evolve.
• Provide QA input to new and revised business processes and systems.
• Promote a proactive, risk-based quality culture.

External Partner and Vendor Oversight

• Oversee external development, manufacturing, testing, packaging, storage and distribution partners.
• Establish clear quality governance, communication and escalation arrangements with external partners.
• Lead the negotiation, approval and maintenance of quality agreements that define responsibilities, standards and interfaces.
• Monitor vendor performance, quality systems and controls; escape and manage risks and issues.
• Lead or participate in vendor quality review meetings, as required.

Vendor Audits and Compliance

• Develop and manage a risk-based audit programme for GMP/GDP-critical partners.
• Plan and conduct vendor audits; issue clear reports and communicate findings.
• Assess findings and oversee CAPA implementation, effectiveness and closure.
• Use audit outcomes and performance data to guide supplier oversight and risk management.

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 escalates 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

• 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.
• 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 .

Salary: Competitive salary and comprehensive employee benefits