Quality Control Lead
- Permanent
- Technical Operations, Quality Control, Microbiologist
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Hobson Prior are searching for a Quality Control Lead to join a Research Centre on a permanent basis in Stevenage. Our client focuses on advancing the growth of cell and gene therapy research across the UK, helping to promote the use of these therapies throughout the health services all over the world. This role is essential in ensuring that the new facility's QC laboratories and the services they provide meet the standards and expectations of the regulatory authorities and Collaborators.
Job Responsibilities:
- Provide leadership and line management supporting a growing group of specialists and technicians.
- Responsible for maintaining a comprehensive facility bio-safety program.
- Supporting the Head of Quality Control with project delivery and project management.
- Emphasising and maintaining within the team a strong GMP knowledge base and work ethic.
- QC laboratory work scheduling and resource allocation ensuring efficient operation.
- Technical training and coaching of the Quality Control group.
- Transfer and validation of collaborator methodologies into QC.
- Establishing a portfolio of Pharmacopeial tests into QC.
- Assisting in the recruitment of new employees as the group's capability expands.
- Development of QC departmental performance measures, metrics and reporting tools and delivery of the same on periodic basis.
- Lead Out of Specification Investigations and disposition.
- Deputise for the Head of Quality Control when required.
- Support biosafety test validations and method qualifications.
- Ensure the QC function operates to a high standard and complies with cGMP and other appropriate regulatory standards.
- Support to ensure all QC laboratory equipment is maintained fit for purpose (qualified and calibrated appropriately and with the appropriate degree of periodicity).
- Generate, review and approve cGMP documentation such as Standard Operating Procedures, Analytical Test Methods, Analytical Test Qualification protocols and reports etc.
Key Skills:
- Highly motivated, pragmatic and practical to support the mission of the organisation to assist in the acceleration of the development of a commercial cell-based therapy industry in the UK.
- Able to evaluate complex situations and find solutions for them in a professional manner.
Requirements:
- Bachelor's degree in Microbiology, Biotechnology, Molecular Biology, or related discipline.
- Minimum of 5 years' experience working at a supervisory level in QC in a GMP licensed aseptic (bio)pharmaceutical manufacturing environment.
- Proven experience of writing and reviewing GMP documents.
- Proven experience of looking critically at own and others work practices and procedures and identifying and implementing any needed improvements.
- Proven experience of motivating teams, whilst training and acting as a role model for employees associated with the GMP QC laboratories.
- Experience in interacting with the regulatory authorities.
- Experience in interacting with clients and collaborators.
Apply now:
If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.
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