Head of Validation
* 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.
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
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.
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
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