Hobson Prior are currently working with a clinical-stage immuno-oncology company who are looking for a QA Director to join them on a permanent basis in Hertfordshire. You will have the responsibility to lead and build the Quality Assurance team at the Stevenage site to support a quality focused culture.
- Communicate with the Director of Quality, based in the USA, to prioritize, schedule and review QMS activities with staff and external contractors.
- Act as primary interface for day-to-day quality issues and longer-term strategic planning activities.
- Primary QA representative for the organisation at the Collaborator Quality Forum.
- Ensure the organisation is ready for regulatory inspections from MHRA and other agencies, which may include HTA and FDA. Ensure staff are trained on inspection readiness.
- Assist with the development and management of the site's Site Master File and Quality Management System, including authoring and approving policies and procedures, active participation in change control, risk management, deviation investigations and root cause analysis.
- Provide quality oversight and internal batch review for manufacturing and associated operations involved in processing patient material for clinical trials.
- Perform internal and external audits and oversee vendor qualification activities ensuring all suppliers are appropriately approved.
- Review and approve validation protocols and qualification reports.
- Oversee the training program at the facility, ensuring staff training is completed timely and appropriately documented.
- Attend project plan meetings and provide status updates on Quality Assurance as required.
- Provide Quality leadership and support for the organisation's technology transfer programs.
- Ability to effectively negotiate and build collaboration amongst individuals and a wide range of functional teams.
- Good interpersonal, verbal and written communication skills.
- Comfortable in a fast-paced small company environment with minimal direction.
- Bachelor's degree in the biological sciences or related field.
- You will have the knowledge and ability to apply GMPs in conformance with FDA, MHRA, EU and ICH standards.
- Experience hosting and managing external inspections.
- You will have a minimum of 8 years progressive quality assurance experience in a pharmaceutical, biotech, or biologics operation, or equivalent education/work experience.
- A background in clinical or commercial Advanced Therapy Medicinal Therapies, ATMPs, would be advantageous.
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.
€90000 - €100000 per annum
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