Company Description
Freeline is a publically listed clinical-stage biotechnology company headquartered in the UK with offices in Germany and the USA. We have an ambitious vision to create better lives for people suffering from chronic systemic diseases using gene therapy as a one-off curative treatment. Freeline has a clear focus on gene therapy (AAV) targeting the liver with the aim to provide treatments for diseases with significant unmet patient needs.
Our gene therapy treatment builds upon the pioneering, world renowned work by the Freeline CSO, Professor Amit Nathwani. His award winning scientific work has already been life changing for patients with Haemophilia B by making gene therapy safe, effective and reliable.
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Innovation and entrepreneurial spirit is at our core, but our passion is working together as one team and tangibly making life changing impact. We are therefore looking for talented and passionate professionals who are driven and team orientated. If you share our vision for excellence and are looking for a high paced work environment, you may be a great fit for our team.
The QA Director will primarily be responsible for supporting PQS and GxP compliance activities at Freeline
Position
- Deputise for Vice President QA and Director QA (US) as required
- Line management responsibility for UK-based QA Managers
- Assist VP QA with QMS design, implementation and maintenance activities
- Ensure that Freeline has a compliant and efficient QA framework and operation to enable GMP activities in Freeline's manufacturing module at the Catapult Cell and Gene Therapy Manufacturing Centre in Stevenage
- Ensure that Freeline has a compliant and efficient QA framework and operation to enable QA oversight of work executed at third party GxP service providers
- Review annual GxP audit schedules
- Lead complaint investigations and participate in recalls
- Perform self-inspections of activities performed by Systems, Documentation and Training team and assist with audits of other QA departments as required
- Represent QA at CMC project meetings
- Responsible for Site Master File (SMF)
- QA approval of risk assessments and Control Strategies
- Participation in Catapult Collaborator Quality Forums as required
- Chair GxP meetings with operational line managers (GCP, GMP and GLP)
- EU GxP regulatory surveillance
- Ensure efficient operation of the vendor assurance programme and maintenance of the Approved Supplier List
- Support the team as required providing guidance and where necessary technical /QA input into Change Controls, Deviations, OOS reports, investigations and CAPAs
- Lead Quality investigations and perform risk assessments as required
- QA Lead for qualification, validation and technology transfer activities at UK sites
- Conduct external audits of GMP service providers as required
- Conduct internal audits of QMS elements and selected GxP processes as required
- Co-host Competent Authority inspections
- Other QA tasks as required
Requirements
- Educated to degree level or equivalent in a biological or physical science
- Experience in pharmaceutical industry, minimum fifteen years GMP experience of which at least ten must be in a QA role and at least two years' experience working with ATMPs
- Competent Authority (e.g. MHRA, US FDA) inspection experience
- Prior experience auditing contract manufacturers and suppliers
- Excellent planning and organisational skills
- Ability to work in a small team in a dynamic environment
- Significant experience and/ or familiarisation with Microsoft Office applications (specifically Word and Excel)
- Ability to travel to work partners in Europe and US as the role requires
- Excellent working knowledge of ATIMP requirements
- Awareness and understanding of GCP requirements
- Excellent interpersonal skills
- Excellent verbal and written communication and computer literacy skills
- Effective time management
- Strong analytical and problem-solving skills
Other information
- Previous ‘hands on' manufacturing experience
- Previous ‘hands on' GCP experience
- Trainee or aspiring Qualified Person (QP)
- Qualified Person (QP) status would be an advantage but not essential
- Experience implementing electronic document management systems would be an advantage but not essential
Job type
Permanent
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Location
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Stevenage, Hertfordshire
