Quality Assurance Manager

Job Description

Blackfield Associates is partnered with a leading biotech organisation based in Cambridge in the search for a Quality Manager.

As the Quality Manager, you will play an active role in the company’s goal to achieve and maintain compliance with current Good Manufacturing Practices (cGMP), in line with both EU and FDA requirements.

Key responsibilities within the position will be to (not limited to):

• Contribute to the implementation of key Quality elements in line with cGMP, taking the lead where required.

• Take responsibility for the ongoing management of the Quality Management System (QMS) as a senior member of the QA Team. This includes supplier management, internal audits/self-inspections, stability programs, change control, deviations, investigations, corrective actions, and risk management.

• Support and host audits conducted by customers and regulatory bodies.

• Deliver both group and individual training sessions on QMS and cGMP topics.

• Maintain QMS documentation, ensuring accurate records in line with company policies and cGMP regulations.

• Advocate compliant and efficient application of cGMP and the Quality Management System, fostering positive collaboration within the business.

• Lead the team to achieve excellence while nurturing personal and professional development.

The ideal candidate for this opportunity will have broad experience in cGMP Quality Assurance and Quality Management Systems, coupled with a self-motivated and diligent approach and a pragmatic mindset. They will be an enthusiastic and experienced people manager with a passion for leading teams, fostering development, and driving excellence. Exceptional attention to detail, strong investigative thinking, and the ability to prioritise effectively are essential. The candidate should also be comfortable working both autonomously and collaboratively to ensure the successful implementation and maintenance of quality systems.