Head of QA
- Experience Level
An excellent opportunity has arisen for a Head of QA to join top pharmaceutical organisation in Stevenage. With guidance from the Quality Director, this position will make sure that the Manufacturing Centre meets the standards and expectations of two key stakeholders; the regulatory authorities and existing as well as potential new collaborators.
- Direct report to the Quality Director with close interaction with the Manufacturing Centre management team.
- Partake with or delegate for the QA Director in managing collaborator interactions and securing new business.
- To assist the Quality Director with the recruitment and development of a high performing Quality team.
- Accountable to lead the preparation for and the management of regulatory agency and collaborator inspections (this may include audit co-hosting with the QA Director).
- Ensure the QMS is fit for purpose for a multi-purpose, multi-collaborator facility.
- To provide general quality subject matter expertise.
- To provide compliance support by providing advice and facilitating the escalation of compliance issues through the appropriate routes.
- Any other assigned duties.
- Ability to evaluate complex situations and find solutions for them in a professional manner.
- Project ownership and pride in its delivery.
- A passion for delivering excellent customer service in a cost-effective way.
- Flexibility towards work assignments and new learning.
- Ability to manage multiple and varied tasks and prioritize workload with attention to detail.
- Requires a degree level in a life sciences discipline.
- Previous experience of building and establishing GMP quality systems in a Phase III / commercial biologicals, vaccines, cell or gene therapies manufacturing facility.
- An understanding of and experience with the application of Eudralex Volume 4, Annex 11 & 15 requirements as they relate to validation/qualification processes.
- You are eligible to act as a Qualified Person under the Permanent Provisions of 2001/83/EC.
- Earlier exposure to R&D interfacing environment.
- Experience in interacting with the regulatory authorities.
- Experience in interacting with clients and collaborators.
- Extensive knowledge of EU / MHRA and US FDA regulatory environments.
- Familiar with global standards related to quality e.g. ISO 9001.
- Significant experience working as a senior quality manager in biologics and preferably cellular and/or gene therapies.
- Track record of successful line management.
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.
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