STEM Recruitment Partners is working with a leading life sciences company in Westmeath to recruit a Quality Manager for their dynamic team. This is a high-impact, permanent role within the organizations Quality function, reporting directly to the Global Quality Director. You will lead a team and manage a team of 4 individuals, that consists of 1 QC/QA Tech lead, 2 QC Lab Technicians and 1 Quality Specialist. About the Company This rapidly growing company is a recognized leader in developing and manufacturing biopolymers for the medical device and pharmaceutical industries. Since entering the Irish market just a few years ago, they have completed the fit out of a state-of-the-art lab and manufacturing plant and have further plans for future expansion. Key Responsibilities Represent the company during audits and site visits. Ensure the quality management system (QMS) is effectively implemented and maintained. Report on QMS performance and recommend improvements to top management. Drive regulatory and customer requirements awareness across the organization. Lead and supervise Quality Assurance Specialists and Quality Control Technicians. Oversee the QMS and ensure compliance with standards like ISO 13485, ISO 9001, and EXCiPACT. Manage documentation, training, and compliance strategies. Direct sub-teams to achieve quality improvements and complete assigned tasks. Guide the design and commercialization of innovative products. Manage projects by delegating tasks and making key decisions. Represent the company during audits and inspections. Develop technical documentation aligned with regulatory standards. Conduct management reviews in the capacity of a quality representative. Manage Corrective and Preventive Actions (CAPAs) and Non-Conformance Reports (NCRs). Lead audit preparations and regulatory requirement adherence. Foster collaboration and positive communication across teams. Job RequirementsEducation Bachelors degree (Level 8 or higher) in science, technology, engineering, or manufacturing. Masters or PhD is beneficial but not required. Experience & Knowledge 7+ years of experience in the pharmaceutical or similar industry, including leadership roles. Strong knowledge of pharmaceutical/chemical manufacturing is advantageous. Expertise in QMS management and regulatory compliance (e.g., ISO 13485, ISO 9001). Hands-on experience with CAPAs, NCRs, change management, and customer complaints. Familiarity with medical device regulations, process validation, and equipment qualification. Proficiency in Six Sigma and Lean methodologies. Skills Advanced problem-solving and decision-making abilities. Proven leadership and project management experience. Certified auditor qualifications (e.g., IRCA Lead Auditor) are a plus. Strong track record in cross-functional product development teams. Skills: Quality Assurance CAPA People Management