Hobson Prior are looking for an Interim Head of QA to join a growing biotech in London on a permanent basis. You will participate in the translation of strategic direction into a framework of Quality processes and systems that defines, directs and governs the tactical application of GMP compliance maintenance.

Job Responsibilities:

• Direct report to the Director of Quality with close interaction with the Manufacturing Centre management team.
• Lead the preparation for and the management of regulatory agency and Collaborator inspections (this may include audit co-hosting with the Director of Quality).
• Partake with or delegate for the Director of Quality in managing collaborator interactions and securing new business.
• You will assist the Director of Quality with the recruitment and development of a high performing Quality team.
• Ensure the QMS is fit for purpose for a multi-purpose, multi-Collaborator facility.
• Provide compliance support by providing advice and facilitating the escalation of compliance issues through the appropriate routes.
• Deliver general quality subject matter expertise.

Key Skills:

• Able to evaluate complex situations and find solutions for them in a professional manner.
• Project ownership and pride in its delivery.
• Having a passion for delivering excellent customer service in a cost-effective way.

Requirements:

• Degree level in a life sciences discipline.
• Previous experience in interacting with the regulatory authorities.
• Experience of building and establishing GMP quality systems in a Phase III/commercial biologicals, vaccines, cell or gene therapies manufacturing facility.
• Previous exposure to R and D interfacing environment.
• 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.
• Substantial experience working as a senior quality manager in biologics and preferably cellular and/or gene therapies.
• Track record of successful line management.

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.