Quality Assurance Manager (Biotech)

Axion Search Limited; Oxford; Hybrid; GBP 50,000 - 75,000; Full time

Job summary

A leading biotechnology company in the UK is seeking a Quality Assurance Manager to ensure GxP compliance across their operations. This pivotal role involves maintaining quality systems, leading audits, and providing oversight for manufacturing and clinical operations, all while supporting the advancement of therapies for rare diseases. The position offers a competitive salary, flexible hybrid working, and a collaborative culture focused on quality and innovation.

Benefits

Competitive salary

Flexible hybrid working

Robust benefits

Collaborative culture

Qualifications

• 5+ years in a GxP quality environment, ideally within biotech.
• Experience supporting MHRA/EMA inspections.
• Strong working knowledge of ICH, EudraLex, and ISO guidelines.

Responsibilities

• Maintain and optimise the QMS across GCP and GMP activities.
• Lead internal/external audits and CAPA processes.
• Provide QA oversight across manufacturing, analytics, and clinical operations.

Skills

GxP compliance

Quality Management Systems (QMS)

Audit leadership

CAPA processes

SOP development

Regulatory oversight

Job description

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.