Hobson Prior are looking for an QA Lead to join a Research Centre on a Fixed-Term contact in Stevenage. Our client focuses on advancing the growth of cell and gene therapy research across the UK, helping to promote the use of these therapies throughout the health services all over the world.

Job Responsibilities:

• Direct report to the Head of Quality Assurance with close interaction with the organisations manufacturing centre management team.
• Develop the manufacturing centre US cGMP compliance strategy.
• Lead collaborations with subject matter experts, including external collaborators, to deliver a US cGMP compliant PQS.
• Provide expert input and advice on US FDA requirements.
• Responsible for day to day management of the PQS update project, reporting to wider management on project progress and managing and escalating project risks.

Key Skills:

• Project ownership and pride in its delivery.
• Ability to manage multiple and varied tasks and prioritize workload with attention to detail.
• Good written and oral communication skills and presentation skills.
• Proven ability to engage constructively with colleagues at all levels across different departments to deliver objectives.
• Ability to quickly establish credibility and build rapport and trust.
• Comfortable operating autonomously once goals and objectives are set.

Requirements:

• Ideally educated to Degree level in a life sciences discipline.
• Experience in interacting with regulatory authorities, specifically US FDA.
• Knowledge of EU/MHRA and FDA regulatory requirements, specifically for aseptic manufacturing, ideally for cell and gene therapy products.
• Experience in participating in/leading/hosting US FDA GMP inspections for aseptically manufactured projects.
• Practical experience in delivering PQS improvements.
• Experience in multi-product manufacturing environments.

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.