VP Global External Quality

Oxford Biomedica; Oxford; On-site; GBP 140,000 - 200,000; Full time

Benefits offered by this job

Wellbeing program

Career development

Inclusive culture

Labs & facilities

Company values

Job summary

Oxford Biomedica is seeking a VP, Global External Quality to lead the development and execution of our external quality strategy. You will oversee data integrity, supplier quality, and client-facing quality activities across a global network, guiding governance and risk management.

You will join the Global Quality Leadership Team, drive quality transformation, audits, and inspections, and partner with manufacturing and regulatory affairs to ensure GMP compliance and lifecycle quality for

Qualifications

• Senior Quality leadership in regulated manufacturing environments.
• Strong knowledge of FDA, GMP, GCP and GLP requirements.
• Experience with regulatory inspections, audits, and QA activities including supplier quality management.
• Data integrity expertise and GMP compliance focus.
• Risk management, validation and qualification principles understanding.

Responsibilities

• Develop and lead the External Quality and Data Integrity strategy across external manufacturing partners and suppliers.
• Embed a proactive quality culture with governance, accountability and risk management.
• Lead quality transformation and continuous improvement across the network.
• Oversee Data Integrity programme aligned with ALCOA+ principles and training.
• Provide senior quality governance for clients, audits, and due diligence.

Skills

Quality leadership

Regulatory knowledge

QMS & GMP

Audits & inspections

Education

Bachelor's degree in Chemistry, Biology, Pharmaceutical Sciences

Advanced degree preferred

Job description

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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.

We’re currently recruiting for a VP, Global External Quality to join our Global Quality team. In this role, you will lead the development and execution of the Global External Quality strategy, providing oversight across data integrity, external manufacturing partners, suppliers, and client-facing quality activities, playing a key part in advancing our mission and making a real difference.

This role can be located close by one of our global locations in Oxford, UK, or Strasbourg or Lyon in France.

Your responsibilities in this role would be to:

• 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.

We are looking for:

• 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.

About Us:

OXB (LSE: OXB) is a global quality and innovation-led contract development and manufacturing organisation (CDMO) in cell and gene therapy with a mission to enable its clients to deliver life changing therapies to patients around the world.

One of the original pioneers in cell and gene therapy, OXB has 30 years of experience in viral vectors; the driving force behind the majority of cell and gene therapies. OXB collaborates with some of the world’s most innovative pharmaceutical and biotechnology companies, providing viral vector development and manufacturing expertise in lentivirus, adeno-associated virus (AAV), adenovirus and other viral vector types. OXB’s world-class capabilities range from early-stage development to commercialisation. These capabilities are supported by robust quality-assurance systems, analytical methods and depth of regulatory expertise.

OXB offers a vast number of technologies for viral vector manufacturing, including a 4th generation lentiviral vector system (the TetraVecta™ system), a dual-plasmid system for AAV production, suspension and perfusion process using process enhancers and stable producer and packaging cell lines.

OXB, a FTSE250 and FTSE4Good constituent, is headquartered in Oxford, UK. It has development and manufacturing facilities across Oxfordshire, UK, Lyon and Strasbourg, France, Bedford MA, and Durham NC, US.

Why Join Us?

• Wellbeing programsthat support your mental and physical health
• Career development opportunitiesto 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

We want you to feel inspired every day. At OXB, we’re future-focused and growing fast. We succeed together—through passion, commitment, and teamwork.