Quality & Regulatory Leader - ISO, Lean & Digital QA

Azenta Life Sciences; Wotton-under-Edge; On-site; GBP 60,000 - 90,000; Full time

Job summary

Azenta Life Sciences seeks a Quality and Regulatory Manager to lead a high-performing quality team and drive product excellence in a fast-paced global setting.

You will own the site's QMS, ensure ISO certifications, and collaborate across functions to embed Right First Time, data-driven decision making, and continuous improvement. This role emphasizes governance, sustainability, and customer satisfaction.

Qualifications

• Experience leading quality in 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.

Responsibilities

• Ensure a safe, compliant workplace aligned with health, safety, environmental, and regulatory standards.
• Own and evolve the site's 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

QMS platforms

Data analytics

Cross-functional leadership

Tools

QMS software

Job description

Azenta Life Sciences seeks a Quality and Regulatory Manager to lead a high-performing quality team and drive product excellence in a fast-paced global setting.

You will own the site's QMS, ensure ISO certifications, and collaborate across functions to embed Right First Time, data-driven decision making, and continuous improvement. This role emphasizes governance, sustainability, and customer satisfaction.