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
EUPermanentQuality
