C&I Quality & Regulatory Manager

Azenta Life Sciences; Wotton-under-Edge; On-site; GBP 85,000 - 110,000; Full time

Job summary

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

You will champion compliance and sustainability while collaborating across functions in a fast-paced, global setting. The role focuses on maintaining ISO9001:2015 and ISO13485, reducing defects through data-driven insights, and embedding Right First Time practices with digital quality 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 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

ISO standards

Data analytics

Cross-functional leadership

Lean Six Sigma

Tools

QMS platforms

ERP

Data analytics tools

Job description

Job Title

C&I Quality & Regulatory Manager

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 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.

If any applicant is unable to complete an application or respond to a job opening because of a disability, please email at [e-mail] for assistance.

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.