Quality and Regulatory Manager

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 are seeking a Quality and Regulatory 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.

Full time, Permanent

Onsite: Wotton, Surrey

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

On-Time Delivery Performance

Compliance Audit Scores

Cost of Poor Quality (PoNC)

What You’ll Bring

• Wealth of 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.