Quality & Regulatory Manager

Azenta Life Sciences; Wotton; On-site; GBP 90,000 - 110,000; Full time

Job summary

Azenta Life Sciences is seeking a C&I Quality & Regulatory Manager to lead a high-performing quality team onsite in Wotton, Surrey. You will drive regulatory and quality compliance, maintain ISO9001:2015 and ISO13485 certifications, and champion continuous improvement across functions.

The role focuses on reducing defects, leveraging data analytics, digital quality tools, and Lean Six Sigma to deliver superior product quality and customer satisfaction in a fast-paced, global environment.

Qualifications

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

Cross-functional leadership

ISO standards

Lean Six Sigma

Digital transformation

Tools

ERP systems

QMS platforms

Data analytics

Job description

C&I Quality & Regulatory Manager

Onsite, Wotton, Surrey

Azenta Life Sciences are seeking a Quality Manager to lead and inspire a high-performing quality team to deliver exceptional product standards and customer satisfaction.

Drive continuous improvement through data-driven insights, advanced quality systems, and collaboration across all functions.

Champion compliance, sustainability, and operational excellence in a fast-paced, global environment.

What You’ll Be Doing

• 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.

Metrics:

• Customer Complaint Reduction
• Defect Rate Improvement
• On-Time Delivery Performance
• Compliance Audit Scores
• Cost of Poor Quality (PoNC)

What You’ll Bring

• 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 methodologies and digital transformation initiatives.

Core Competencies:

• Digital Fluency: Comfortable using ERP, QMS, and data analytics platforms to drive decisions.
• Customer-Centric Mindset: Prioritizes customer experience and quality outcomes in every process.
• Change Leadership: Skilled at leading teams through transformation and continuous improvement initiatives.
• Risk Management: Proactively identifies and mitigates operational and compliance risks.
• Data-Driven Decision Making: Uses metrics, trend analysis, and predictive tools to guide quality strategies.
• Collaboration & Influence: Builds strong relationships across functions and geographies to achieve shared goals.
• Innovation Orientation: Seeks out new technologies and methods to enhance quality and efficiency.
• Sustainability Awareness: Integrates environmental and social responsibility into quality practices