At a Glance
- Tasks: Lead global quality strategy and ensure compliance across external partners and suppliers.
- Company: Join OXB, a pioneering company in cell and gene therapy.
- Benefits: Competitive rewards, wellbeing programmes, and career development opportunities.
- Other info: Collaborative culture with state-of-the-art facilities and a focus on innovation.
- Why this job: Make a real impact in advancing life-changing therapies for patients worldwide.
- Qualifications: Bachelor's degree in a scientific discipline; extensive experience in quality leadership required.
Join Us in Changing Lives. 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.
Why Join Us? Competitive total reward packages, wellbeing programmes 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.
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.
VP Global External Quality in Banbury employer: Oxford BioMedica (UK) Limited
At OXB, we pride ourselves on being a leading employer in the field of cell and gene therapy, offering a supportive and inclusive work culture that prioritises employee wellbeing and career development. Our state-of-the-art facilities in Oxfordshire provide an inspiring environment where passionate individuals can thrive, collaborate, and contribute to life-changing therapies that make a real difference in patients' lives. Join us and be part of a team that embodies our core values: Responsible, Responsive, Resilient, and Respectful.
Contact Details:
Oxford BioMedica (UK) Limited Recruitment Team
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