Quality & Regulatory Manager — ISO & Continuous Improvement

Azenta US, Inc.; United Kingdom; Remote; GBP 70,000 - 100,000; Full time

Job summary

Azenta UK, Ltd. seeks a senior C&I Quality & Regulatory Manager to lead a high-performing quality team, sustain ISO9001:2015 and ISO13485 certifications, and drive continuous improvement across global operations.

This role champions compliance, sustainability, and operational excellence in a fast-paced biopharma support environment. You will partner with operations, engineering and supply chain to reduce defects, embed Right First Time principles, and deploy Lean/Six Sigma and digital tools to

Qualifications

• Minimum 5+ years of quality leadership experience in manufacturing or regulated environments.
• Strong knowledge of ISO9001:2015, ISO13485 and QMS platforms.
• Proven ability to drive improvements using data analytics and digital tools.

Responsibilities

• Ensure a safe, compliant workplace aligned with health, safety, environmental and regulatory standards.
• Own and evolve the site's Quality Management System to maintain ISO certifications and readiness for future standards.
• Lead initiatives to reduce defects and customer complaints through root cause analysis and preventive strategies.
• Partner with operations and engineering to embed Right First Time principles and digital quality tools.
• Drive continuous improvement using Lean, Six Sigma, and automation to optimize processes and enhance customer experience.
• Oversee audits, compliance programs, and corrective actions with rigor.
• Coach and develop team members, fostering accountability and collaboration.

Skills

Quality leadership

ISO standards

QMS platforms

Data analytics

Cross-functional leadership

Lean Six Sigma

Digital transformation

Tools

ERP systems

QMS software

Data analytics tools

Job description

Azenta UK, Ltd. seeks a senior C&I Quality & Regulatory Manager to lead a high-performing quality team, sustain ISO9001:2015 and ISO13485 certifications, and drive continuous improvement across global operations.

This role champions compliance, sustainability, and operational excellence in a fast-paced biopharma support environment. You will partner with operations, engineering and supply chain to reduce defects, embed Right First Time principles, and deploy Lean/Six Sigma and digital tools to