Global Quality & Regulatory Leader

Azenta Life Sciences; Wotton; On-site; GBP 80,000 - 110,000; Full time

Job summary

Azenta Life Sciences is seeking a Quality and Regulatory Manager to lead a high-performing quality team in a fast-paced, global setting.

You will own the QMS, maintain ISO9001:2015 and ISO13485 readiness, and drive improvements through data-driven insights, Lean/Six Sigma, and digital tools. The role collaborates across operations and engineering to ensure exceptional product quality and regulatory compliance.

Qualifications

• Leadership experience in manufacturing or regulated environments.
• Strong knowledge of ISO standards, QMS platforms, and data analytics.
• Proven ability to lead cross-functional teams and manage change.
• Experience with Lean/Six Sigma and digital transformation initiatives.

Responsibilities

• Ensure a safe, compliant workplace aligned with regulatory standards.
• Own and evolve the site’s QMS to maintain ISO9001:2015 & ISO13485 certifications.
• Lead initiatives to reduce defects and customer complaints via root cause analysis.
• Partner with operations and engineering to embed 'Right First Time' principles and digital tools.
• Drive continuous improvement using Lean, Six Sigma, and automation.
• Oversee audits, compliance programs, and corrective actions.
• Coach and develop team members, fostering accountability and collaboration.

Skills

Quality leadership

Regulatory

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 Life Sciences is seeking a Quality and Regulatory Manager to lead a high-performing quality team in a fast-paced, global setting.

You will own the QMS, maintain ISO9001:2015 and ISO13485 readiness, and drive improvements through data-driven insights, Lean/Six Sigma, and digital tools. The role collaborates across operations and engineering to ensure exceptional product quality and regulatory compliance.