Reference Number: JO-2007-451979
Director of Quality
Job Type: Permanent
Director of Quality
Salary details available on discussion + excellent benefits package including stock options
My client is a clinical stage T cell immunotherapy company developing products to treat and prevent infectious disease and cancer.
The companys proprietary heterologous prime-boost platform comprises Chimpanzee Adenovirus Oxford (ChAdOx) and Modified Vaccinia Ankara (MVA), two non-replicating viral vectors which safely mimic viral infection in human cells and elicit high magnitude, durable, targeted CD8+ and CD4+ T cell responses to clear foreign pathogens and tumours.
The platform was licensed from the prestigious Jenner Institute for vaccine research at the University of Oxford, which dedicated over 20 years of research to identify and refine the optimal method for CD8+ T cell induction in humans. This platform has generated a robust, largely immunotherapeutic pipeline of seven clinical product candidates for infectious disease and cancer indications, four of which are in co-development with partners and external funding and one which is fully out licensed.
Due to exciting expansion across the company, with offices in the UK (headquarter), USA, Italy and Australia, they are now recruiting for this new position, which can be part home based, fulltime (37.5 hours per week) and a permanent contract.
If you are looking for the opportunity to develop yourself, a team and a department then this could be just the role for you. With excellent development opportunities and the chance to be part of this rapidly expanding, market leading biotech, now really is the time to get in contact to explore further.
The role will be responsible for all Quality activities related to the development and progression of the organisation which will include; design, development, delivery and execution of the Global QA strategy including audit and inspection management, QMS management, GCP and GMP oversight and lead on the assurance of compliance for all projects, products and programs. PLEASE NOTE: This role will require travel globally (% TBC).
Other key responsibilities will include:
Input to development plans and programs to ensure appropriate Quality strategies are executed in accordance with the overall development plans;
Ensure good practices (GxP) are adopted and implemented throughout the organisation;
Maintain detailed working knowledge of the Quality environment through direct and indirect contact with agencies and industry groups including MHRA, EMA, FDA etc;
Work with staff, external consultants and advisors to ensure Quality compliance and take accountability for ensuring the company maintains its Inspection Ready status;
Provide Quality expertise and oversight internally to project teams and other departments;
Maintain a constant and current knowledge of global Quality intelligence, advising the business of any potential impacts with regards to changes in regulations and guidelines and recommending appropriate course of actions;
Prepare and manage the Quality annual budget;
Maintain and develop the QMS to ensure ongoing compliance with regulatory standards and regulations;
Delivering Quality training (GCP, GMP, GLP) to staff;
Managing QMS training for new and existing staff.
Manage annual External/Contract Service Provider audit programme;
Manage internal audit programme including audit schedules;
Perform internal, Contract Service Provider and investigator site audits;
Manage independent auditors;
Host regulatory authority inspections.
Ensuring compliance with GCP, GMP and other regulatory requirements;
Make sure that Quality systems support optimal day-to-day operations and projects;
Successful applicants must be able to demonstrate management experience as well as a strong understanding of pharmaceutical QA, GCP and GMP experience within a clinical quality/pharmaceutical manufacturing environment (10 years) ideally as well as experience of both developing audit procedures, to include hosting and conducting across local and global regions.
You must also be able to show:
The ability to establish and maintain effective working relationships with internal and external stakeholders.
Extensive/demonstratable knowledge of GXP pharmaceutical procedures.
Demonstrated knowledge, understanding and application of GCP and GMP guidelines and regulations.
Fluent English communications skills (written & spoken).
Ability to interpret complex data and present key findings.
To apply for this role, please call Bob Beevers at Clinical Professionals on +44 07908 011 616 or send an updated version of your CV via email to email@example.com
If this role is not for you, we do operate a bonus referral scheme should we go on to successfully place someone that you recommend to us so please feel free to share these details within your network.