Senior Director, Head of Validation

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 Head of Validation. In this role, you will be accountable for OXB UK qualification / re-qualification / validation activities of its GxP facilities / equipment / systems and processes.  Develops the Validation function’s capability and strategic direction as well as leading the team to ensure that the appropriate regulatory, quality and service level requirements are delivered in a robust, science and risk-based approach., playing a key part in advancing our mission and making a real difference.

Your responsibilities in this role would be:

• Defining the strategic direction of the Validation function with the Site Leadership Team.
• Accountable for leading the Validation function; building the team and capabilities, establishing a clear vision, setting and managing departmental budget, coaching, mentoring, recruitment, training and performance management.
• Ensures that OXB’s GxP facilities, equipment, systems, including computer systems, & processes are qualified and validated in accordance with the relevant regulatory requirements of the countries/markets in which the business operates.
• Works collaboratively across the business to ensure that Validation-related processes and procedures are well-represented in OXB/strategic partner product programmes, regulatory submissions and in all CMC responses to regulatory agencies. 
• Drive a science and risk-based strategy to ensure the right level of qualification and validation are achieved in a compliant way.
• Engages with OXB’s strategic partners and collaborators in promoting the Company’s qualification/re-qualification/validation activities and to reinforce OXB’s credibility.
• Proposes functional strategy/tactics/performance to the senior management internally. Regularly presents strategic and performance information and influences the leadership team on validation technical and regulatory considerations.
• Actively works with internal/external team members to define and agree the most appropriate functional strategy/tactics for qualification/validation of OXB’s client programs.
• Ensures validation master plans (VMPs), programs of work, protocols and procedures are established which facilitate the delivery of qualification/re-qualification/validation activities to the required quality and regulatory standards.
• Manages the qualification/requalification/validation deliverables to meet third party/client and user/system-owner schedule/timeline requirements.
• Leads and empowers the Validation team in identifying, assessing and adopting (as appropriate) validation/ qualification process improvements and better ways of working.
• Maintains an active awareness of developments in regulatory standards and industry best practices which may impact the qualification and validation requirements.

We are Looking For:

• Degree in Science / Engineering or similar
• Strong technical and regulatory knowledge of validation/ qualification requirements associated with facilities, equipment and systems, bulk manufacturing, fill-finish, sterilisation, sanitisation/cleaning and cold-chain distribution gained within a biopharmaceuticals or relevant pharmaceuticals industrial environment.
• Knowledge and understanding of Environmental, Health & Safety (EHS) requirements as they impact the Validation function and associated activities.
• A strong track record of establishing validation master plans (VMPs), protocols and procedures which facilitate the delivery of qualification/validation activities to the required quality and regulatory standards.
• Knowledgeable of GxP, CMC, ICH and compendial (USP/EP/JP) regulatory requirements. Knowledge of relevant regulatory agency guidance including ICH, FDA, EMA, and authorities in other major geographic areas is essential

About Us:

OXB is a quality and innovation-led viral vector CDMO 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, we have more than 30 years of experience in viral vectors; the driving force behind the majority of 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) and adenoviral vectors. OXB’s world-class capabilities span 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.

Ready to Make a Difference?

Collaborate. Contribute. Change lives.