Location: UK (Oxford, Hybrid) | Job Ref: AXQAM003
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.
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