Senior Director, Head of Validation

New Today

Company description:
OXB is a quality and innovation-led viral vector CDMO that enables its clients to deliver life-changing therapies to patients around the world. One of the original pioneers in cell and gene therapy, OXB has more than 30 years of experience in viral vectors, the driving force behind the majority of gene therapies.
Cell and gene therapy is the treatment of disease by the delivery of therapeutic genetic material (DNA or RNA), into a patients cells. One highly effective approach to delivering genetic information is to re-engineer existing viruses to be safe delivery vehicles (vectors) to insert the genetic material into patients cells. This can be achieved either by directly administering the vector to the patient (often referred to as in vivo gene therapy), or by first introducing the genetic material to cells or tissue outside of the body, before administering the cells or tissue into the patient (often referred to as ex vivo gene therapy or gene-modified cell therapy).
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.
Job description:
Join Us in Changing Lives
At OXB , our people are at the heart of everything we do. Were on a mission to enable life-changing therapies to reach patients around the worldand were looking for passionate individuals who embody our core values every day: Responsible, Responsive, Resilient, and Respectful .
Were currently recruiting for a Head of Validation . In this role, you willbe accountable for OXB UK qualification / re-qualification / validation activities of its GxP facilities / equipment / systems and processes. Develops the Validation functions 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 OXBs 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 OXBs strategic partners and collaborators in promoting the Companys qualification/re-qualification/validation activities and to reinforce OXBs 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 OXBs 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 worlds most innovative pharmaceutical and biotechnology companies, providing viral vector development and manufacturing expertise in lentivirus, adeno-associated virus (AAV) and adenoviral vectors. OXBs 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 programmesthat 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, were future-focused and growing fast. We succeed togetherthrough passion, commitment, and teamwork.
Ready to Make a Difference?
Collaborate. Contribute. Change lives.
We offer:
Oxford Biomedica is a quality and innovation-led viral vector CDMO that enables its clients to deliver life-changing therapies to patients around the world. One of the original pioneers in cell and gene therapy, Oxford Biomedica has more than 25 years of experience in viral vectors, the driving force behind the majority of gene therapies.
Cell and gene therapy is the treatment of disease by the delivery of therapeutic genetic material (DNA or RNA), into a patients cells. One highly effective approach to delivering genetic information is to re-engineer existing viruses to be safe delivery vehicles (vectors) to insert the genetic material into patients cells. This can be achieved either by directly administering the vector to the patient (often referred to as in vivo gene therapy), or by first introducing the genetic material to cells or tissue outside of the body, before administering the cells or tissue into the patient (often referred to as ex vivo gene therapy or gene-modified cell therapy).
Oxford Biomedica 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. Oxford Biomedica'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.

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Location:
Cowley
Salary:
not provided
Job Type:
FullTime
Category:
Management

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