C&I Quality & Regulatory Manager

Azenta UK, Ltd.; Wotton; On-site; GBP 65,000 - 90,000; Full time

Job summary

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

You will drive continuous improvement through data-driven insights, advanced quality systems, and cross-functional collaboration to ensure regulatory compliance and customer satisfaction. Responsibilities include owning the QMS, reducing defects, and guiding the organization toward Right First Time with Lean, Six Sigma, and digital 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 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.
• Lead initiatives to reduce defects and customer complaints through root cause analysis and predictive analytics.
• 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.
• Oversee audits, compliance programs, and corrective actions with rigor and transparency.
• Coach and develop team members, fostering accountability, innovation, and collaboration.

Skills

Quality leadership

ISO standards

QMS platforms

Data analytics

Lean / Six Sigma

Tools

ERP

QMS tools

Data analytics platforms

Job description

Azenta UK, Ltd.

At Azenta, new ideas, new technologies and new ways of thinking are driving our future. Our customer focused culture encourages employees to embrace innovation and challenge the status quo with novel thinking and collaborative work relationships. All we accomplish is grounded in our core values of Customer Focus, Achievement, Accountability, Teamwork, Employee Value and Integrity

Job TitleC&I Quality & Regulatory Manager Job Description

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.

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.

Metrics

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

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 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.

Azenta is an Equal Opportunity Employer.

This company considers candidates regardless of race, color, age, religion, gender, sexual orientation, gender identity, national origin, disability or veteran status.

Azenta is a market leader in automated bio sample management solutions and multiomics services across areas such as drug development, clinical and advanced cell therapies for the industry's top pharmaceutical, biotech, academic and healthcare institutions globally. We provide unparalleled capabilities with our lab analysis, sample management and storage services, informatics software, and consumables, with the largest installed base managing over 1 billion samples globally. As a global leader in R&D multiomics services, Azenta Life Sciences, leads the way in providing superior data quality with unparalleled technical support to enable researchers around the world to advance their scientific discoveries faster than ever before.