Overview

A high-growth, global life sciences manufacturing organisation is seeking an experienced Quality Manager to lead and evolve its site-wide Quality function.

This is a pivotal leadership role responsible for shaping and scaling the Quality Management System (QMS), ensuring regulatory compliance, and driving continuous improvement across manufacturing operations.

You will play a key role in enabling operational excellence, supporting global customers, and ensuring the organisation is positioned to scale effectively.

Key Responsibilities

• Own and lead the site Quality Management System (QMS), ensuring alignment with internal, customer, and regulatory requirements
• Manage and oversee internal and external audits, ensuring robust compliance and continuous improvement
• Lead the investigation and resolution of non-conformances, deviations, and customer complaints, including CAPA management
• Oversee quality events and manufacturing excursions, ensuring root cause, impact, and corrective actions are clearly defined and executed
• Provide regular reporting to senior leadership on QMS performance, KPIs, and improvement opportunities
• Lead supplier quality and risk management, including audits and performance monitoring
• Develop and maintain Quality Control (QC) processes, ensuring product and material compliance
• Drive process improvement initiatives (Lean / Six Sigma / validation-led improvements) to enhance quality and efficiency
• Build, lead, and develop a high-performing quality team, including hiring, training, and capability development

Experience & Requirements

• Strong experience operating within regulated manufacturing environments (pharma, biotech, or medical devices)
• Deep understanding of ISO standards (9001 / 13485) and cGMP requirements
• Proven experience managing CAPA systems, audits, and quality investigations
• Experience implementing or maintaining Quality Management Systems (QMS)
• Strong knowledge of risk management, validation, and process control methodologies
• Experience working with suppliers and outsourced manufacturing partners
• Ability to apply data-driven and statistical approaches to quality and operational challenges
• Excellent communication and stakeholder management skills, including presenting to senior leadership

Preferred

• Knowledge of global regulatory frameworks (e.g. FDA, EU regulations)
• Exposure to 21 CFR Parts 210/211 and/or 820
• Lean / Six Sigma certification or equivalent experience
• Strong leadership experience within a growing or scaling organisation

Education

• Bachelor’s degree in Life Sciences, Engineering, or related field
• Typically 5+ years’ experience in Quality within a regulated manufacturing environment

Why This Role

• Opportunity to lead Quality within a scaling, high-impact life sciences organisation
• Direct influence on operational performance, compliance, and customer outcomes
• Visibility with senior leadership and ability to shape quality strategy at site level