Develop and lead the global External Quality and Data Integrity strategy, ensuring alignment with corporate objectives, regulatory requirements, customer expectations, and the long-term needs of the external manufacturing and supplier network.
Embed a proactive quality culture across external partners by driving accountability, risk identification, compliance, and quality-focused decision making.
Lead quality transformation and continuous improvement programmes that enhance compliance, operational excellence, digital quality capabilities, risk management, and overall business performance.
Provide strategic leadership and governance as a member of the Global Quality Leadership Team, contributing to enterprise-wide quality strategy, decision making, and cross-functional alignment.
Establish and oversee a comprehensive Data Integrity programme, ensuring compliance with ALCOA+ principles, risk management, training, monitoring, investigations, and remediation across internal and external networks.
Lead Supplier Quality Management, including supplier qualification, risk assessment, quality agreements, performance monitoring, audits, governance, and supplier development programmes to drive compliance, reliability, and performance.
Provide quality oversight for external manufacturing partners, ensuring effective governance, quality reviews, performance management, and risk mitigation.
Act as the senior quality representative for clients and customers, leading quality governance, supporting audits and due diligence, resolving quality issues, and building trusted relationships that support commercial and business development objectives.

Bachelor's degree in Chemistry, Biology, Pharmaceutical Sciences, or a related scientific discipline; advanced degree preferred.
Extensive experience within the biotechnology and/or pharmaceutical industry, including senior Quality leadership roles in regulated manufacturing environments.
Strong knowledge of global regulatory authorities including FDA, GMP, GCP and GLP requirements.
Proven expertise in Quality Management Systems (QMS), with a particular focus on GMP compliance and data integrity.
Demonstrated experience with regulatory inspections, audits, and quality assurance activities, including supplier quality management.
In-depth understanding of risk management, validation and qualification principles, and quality performance metrics.

At OXB, our people are at the heart of everything we do. We're on a mission to enable life-changing therapies to reach patients around the world-and we're looking for passionate individuals who embody our core values every day: Responsible, Responsive, Resilient, and Respectful.
Competitive total reward packages
Wellbeing programs that support your mental and physical health
Career development opportunities to help you grow and thrive
Supportive, inclusive, and collaborative culture
State-of-the-art labs and manufacturing facilities
A company that lives its values: Responsible, Responsive, Resilient, Respect

1 Oxford Biomedica Limited jobs in England & Wales