Quality and Regulatory Manager
Requirements
Requires extensive quality leadership experience within manufacturing or regulated environments. Must possess strong knowledge of ISO standards, QMS platforms, and the ability to lead cross-functional teams through digital transformation.
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
Defect Rate Improvement
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.
Skills
About Azenta Life Sciences
Azenta (Nasdaq: AZTA) is a leading provider of life sciences solutions worldwide, enabling impactful breakthroughs and therapies to market faster. Azenta provides a full suite of reliable cold-chain sample management solutions and genomic services across areas such as drug development, clinical research and advanced cell therapies for the industry's top pharmaceutical, biotech, academic and healthcare institutions globally. Azenta is headquartered in Burlington, MA, with operations in North America, Europe and Asia. For more information, please visit www.azenta.com.
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