Azenta Life Sciences
Quality and Regulatory Manager
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Quality and Regulatory Manager
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.
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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.
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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.
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