Overview:
Our client, a well-established biotechnology company focused on rare diseases is seeking a Quality Assurance Manager to support GxP compliance across their UK operations. This is a pivotal role ensuring quality systems remain inspection-ready as the business advances late-stage trials and prepares for commercialisation.
Key Responsibilities:
Maintain and optimise the QMS across GCP and GMP activities
Lead internal/external audits, CAPA processes, and SOP development
Provide QA oversight across manufacturing, analytics, and clinical operations
Act as QA representative in cross-functional teams (Clinical, Regulatory, CMC)
Requirements:
5+ years in a GxP quality environment, ideally within biotech
Experience supporting MHRA/EMA inspections
Strong working knowledge of ICH, EudraLex, and ISO guidelines
Why Join?
Be part of a biotech advancing therapies for underserved patient populations
Play a key role in strengthening quality operations in preparation for commercial launch
Competitive salary, flexible hybrid working, and robust benefits
Collaborative, agile culture where quality and innovation go hand-in-hand
Equal Opportunities Employer
Axion is an equal opportunities employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
We specialise in recruitment across multiple sectors – let’s talk.
