Senior Quality Assurance Manager

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.

• 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.

• 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; escalate and manage risks and issues.
• Lead or participate in vendor quality review meetings, as required.

• 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.

• 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 elevate quality risks, and ensure quality requirements are reflected in development and manufacturing plans.

• 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…