Quality & Regulatory Leader — ISO & Continuous Improvement

Azenta Life Sciences; Wotton-under-Edge; On-site; GBP 85,000 - 110,000; Full time

Job summary

Azenta UK, Ltd. is seeking a C&I Quality & Regulatory Manager to lead a high-performing quality team, driving product standards and customer satisfaction.

You will champion compliance and sustainability while collaborating across functions in a fast-paced, global setting. The role focuses on maintaining ISO9001:2015 and ISO13485, reducing defects through data-driven insights, and embedding Right First Time practices with digital quality tools.

Qualifications

• 5+ years in quality leadership within manufacturing or regulated environments.
• Strong knowledge of ISO standards, QMS platforms, and data analytics tools.
• Proven ability to lead cross-functional teams and manage change effectively.
• Experience with Lean/Six Sigma and digital transformation initiatives.

Responsibilities

• Ensure a safe, compliant workplace aligned with Health, Safety, Environmental, and regulatory standards.
• Own and evolve the site’s Quality Management System (QMS) to maintain ISO9001:2015 & ISO13485 certifications and readiness for future standards.
• Lead initiatives to reduce defects and customer complaints through root cause analysis, predictive analytics, and proactive prevention 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 and transparency.
• Coach and develop team members, fostering a culture of accountability, innovation, and collaboration.

Skills

Quality leadership

ISO standards

Data analytics

Cross-functional leadership

Lean Six Sigma

Tools

QMS platforms

ERP

Data analytics tools

Job description

Azenta UK, Ltd. is seeking a C&I Quality & Regulatory Manager to lead a high-performing quality team, driving product standards and customer satisfaction.

You will champion compliance and sustainability while collaborating across functions in a fast-paced, global setting. The role focuses on maintaining ISO9001:2015 and ISO13485, reducing defects through data-driven insights, and embedding Right First Time practices with digital quality tools.