- Experience Level
- Senior Management
Hobson Prior are looking for a QA Director for an exciting opportunity to join a top biotechnology company on a permanent basis located in Stevenage. Our client's focus is to develop gene therapies to enable people living with chronic diseases live a better life.
- 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 the organisation has a compliant and efficient QA framework and operation to enable GMP activities in the organisation's manufacturing module.
- Ensure that the organisation 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.
- QA approval of risk assessments and Control Strategies
- Any other assigned duties.
- Excellent planning and organisational skills
- Ability to work in a small team in a dynamic environment
- Excellent interpersonal skills.
- Strong verbal and written communication and computer literacy skills
- Effective time management.
- Strong analytical and problem-solving skills.
- You are educated to degree level or equivalent in a biological or physical science.
- Previous experience auditing contract manufacturers and suppliers.
- Strong working knowledge of ATIMP requirements.
- Awareness and understanding of GCP requirements.
- Previous experience in pharmaceutical industry, at least 15 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.
- 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.
If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" 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.
Apply for QA Director
Already uploaded your CV? Sign in to apply instantly