Quality Manager

STEM Recruitment Partners is partnering with a leading life sciences company in Westmeath to recruit a Quality Manager for their dynamic team on a permanent basis. This is a highly visible and significant role within the organizations Quality function, reporting directly to the Global Quality Director. About the Company This company has grown considerably since entering the Irish market only a few years ago. They are renowned for developing and manufacturing biopolymers for medical device and pharmaceutical companies. Recently they completed the fitout of a brand lab and manufacturing plant and have further plans for expansion in the future. Job Responsibilities: As Quality Manager, your responsibilities will include but are not limited to: Management Representative Duties: Representing the organization during company visits and audits. Ensuring the establishment, implementation, and maintenance of processes required for the quality management system (QMS). Reporting to top management on QMS performance and areas for improvement. Promoting awareness of regulatory and customer requirements throughout the organization. Team Leadership & QMS Management: Supervising Quality Assurance Specialists and Quality Control Technicians. Overseeing the upkeep and maintenance of the QMS. Implementing documentation, training, and strategies to ensure compliance with ISO 13485, ISO 9001, and EXCiPACT standards. Managing sub-teams to drive quality improvements and task completion. Leading activities in the design and development of innovative products, from concept through to commercialization. Project & Audit Management: Delegating tasks and making decisions as part of project management duties. Representing the company in quality-related areas during audits and regulatory inspections. Preparing technical documentation aligned with regulatory requirements and internal processes. Conducting management reviews as the quality representative. Additional Responsibilities: Managing CAPAs and NCRs. Acting as lead representative during audits and guiding teams through regulatory requirements. Contributing to organizational goals through initiative, execution, and a focus on performance and safety. Building collaborative relationships, leveraging diverse talent, and fostering positive communication. Job Requirements To qualify for this role, you should have: Education: A Level 8 or above qualification in a related discipline (science, technology, engineering, or manufacturing). A masters degree or PhD in a related discipline is advantageous but not mandatory. Experience & Knowledge: 7+ years in the pharmaceutical industry or a similar environment, including leadership experience. Strong understanding of pharmaceutical/chemical manufacturing operations. Expertise in QMS management and regulatory compliance (e.g., ISO , ISO 9001). Experience with CAPAs, NCRs, change management, supplier management, and customer complaint resolution. Familiarity with medical device regulations, process validation, and equipment qualification. Proficiency in Six Sigma and Lean methodologies. Skills: Advanced problem-solving, decision-making, and root-cause analysis abilities. Proven project management and team leadership skills. Certified auditor qualifications (e.g., IRCA Lead Auditor) are an advantage. A track record of contributing to successful cross-functional product development teams. This is a unique opportunity to join a leading life sciences organization in a key quality leadership role. If you have the expertise, drive, and leadership skills required, STEM Recruitment Partners would love to hear from you! Skills: Quality Assurance CAPA People Management