Senior Quality Assurance Manager in Oxford

I am hiring for a Senior QA Manager to join an innovative, growing biotechnology company with a developing clinical pipeline.

This is a senior QA position with broad responsibility across the organisation, supporting the progression of development programmes and providing quality leadership across the Gx P landscape.

The role will work across

GMP, GDP and GCP , with particular responsibility for quality oversight of outsourced activities across CMC, manufacturing, testing, clinical supply and clinical development.

You will work closely with internal scientific, clinical and regulatory teams as well as external development, manufacturing, testing and clinical service providers.

The position offers the opportunity to take genuine ownership of quality activities, including vendor governance, quality agreements, audits, deviations, investigations, CAPAs, change controls, quality risk management and inspection readiness.

A key part of the role will also be helping to develop and continuously improve a pragmatic, proportionate and risk-based Quality Management System as the business continues to grow.

This is a hybrid role requiring 3 days per week onsite. This requirement is essential, so please do not apply if you are unable to commit to working onsite 3 days per week.

Responsibilities

• Provide QA leadership and oversight across GMP, GDP and GCP activities.
• Develop, implement and continuously improve risk-based QA policies, processes, procedures and systems.
• Maintain and develop the Quality Management System in line with the organisation's evolving requirements.
• Provide QA oversight of outsourced development, manufacturing, testing, packaging, storage and distribution activities.
• Establish appropriate quality governance, communication and escalation arrangements with external partners.
• Lead the negotiation, approval and maintenance of quality agreements.
• Monitor external partner performance, quality systems and controls and manage associated risks and issues.
• Develop and manage a risk-based audit programme for Gx P-critical suppliers.
• Plan and conduct vendor audits, issue reports and oversee the implementation and closure of CAPAs.
• Provide QA oversight across CMC development, manufacturing and testing activities.
• Review and approve relevant CMC, manufacturing, testing and quality documentation.
• Provide QA oversight of clinical trial material supply, including manufacture, testing, release, packaging, labelling, storage and distribution.
• Oversee quality events relating to clinical supply, including deviations, temperature excursions, complaints and returns.
• Oversee deviations, investigations, CAPAs and change controls across internal and outsourced activities.
• Lead or support root-cause investigations and quality risk assessments.
• Ensure appropriate corrective, preventive and risk-mitigation actions are implemented and effectively closed.
• Provide QA oversight of clinical development activities in accordance with applicable GCP requirements, including ICH E6(R3).
• Support risk-based quality management and appropriate oversight of delegated clinical activities.
• Contribute to regulatory and inspection readiness activities, including preparation, responses and follow-up.
• Review relevant regulatory documentation and submissions from a quality, compliance and data integrity perspective.
• Act as a trusted QA partner to internal stakeholders across development and support functions.
• Provide clear, pragmatic and proportionate quality advice across development activities.
• Contribute to the ongoing development of the organisation's quality strategy and culture.

Requirements

• 8+ years of relevant QA/Gx P experience within the pharmaceutical or biotechnology sector, with increasing responsibility across GMP/GDP and GCP environments.
• Degree in a relevant scientific or technical discipline (pharmacy, pharmaceutical sciences, biology, biochemistry, biotechnology, chemistry or a related life science).
• Extensive practical knowledge of GMP and GDP with significant QA experience within a Gx P environment.
• Strong experience across pharmaceutical or biotechnology development, including CMC, manufacturing, testing and clinical supply.
• Demonstrable experience providing QA oversight of clinical development activities in accordance with GCP requirements, including ICH E6(R3).
• Experience overseeing CROs, CMOs/CDMOs, testing laboratories and other Gx P-critical external partners.
• Experience working within an outsourced development and manufacturing model.
• Strong experience establishing, reviewing, negotiating and maintaining quality agreements.
• Demonstrable experience planning and conducting GMP/GDP vendor audits and overseeing associated CAPAs and follow-up activities.
• Strong experience managing deviations, investigations, CAPAs, change controls and quality risk management.
• Experience providing QA oversight of clinical trial supply and associated GMP/GDP requirements.
• Experience supporting regulatory inspection readiness and regulatory inspections.
• Experience developing, implementing or improving QMS processes, procedures and systems.
• Ability to provide pragmatic, risk-based QA advice within a growing and evolving organisation.
• Strong communication, influencing and stakeholder management skills.
• Ability to work effectively across multiple functions and with external partners.
• Experience within a smaller or growing biotechnology or pharmaceutical organisation would be advantageous.
• A formal quality or auditing qualification would be advantageous.

The ability to work onsite 3 days per week is essential. Please do not apply if you cannot commit to this requirement.

Candidates must already have the right to work in the UK. Visa sponsorship is not available for this position, so applicants must already hold the appropriate UK right to work.

#J-18808-Ljbffr