We are seeking a highly experienced professional to lead our manufacturing operations in Dublin. This is an exciting opportunity to work with a leading multinational organization that values excellence and innovation.
The ideal candidate will have a strong background in managing and executing total quality management systems, particularly in the External Supply organization (Raw Materials Categories, Devices, and Contract Manufacturing).
Key responsibilities include:
1. Executing nonconformance, CAPA, SICAR, Change Control, and metrics oversight.
2. Acting as the category owner for all quality records and procedures.
3. Processing, investigating, and responding to deviations.
4. Addressing and expediting product deviations under the company's quality management system procedures, ensuring compliance with regulatory agencies.
5. Monitoring, investigating deviations, and determining corrective and preventive actions.
6. Maintaining unified product defect investigation operating procedures.
7. Providing technical expertise to optimize deviations management, corrective and preventive actions effectiveness, and prevent reoccurring events.
8. Maintaining and monitoring systems to ensure that all deviations received are appropriately investigated and concluded per the company's quality standards and procedures.
9. Communicating with all levels of the organization, facilitating development of solutions to critical business issues, and effectively defining objectives to enable effective metric generation and reporting.
This position requires 6+ years related work experience in manufacturing, process development, or quality assurance in Biotech or pharmaceutical industry, with demonstrated experience in compliance, problem solving, advanced root cause analysis, critical thinking, project management, and quality systems.
The ideal candidate must have a thorough working knowledge of EU and US cGMPs regulations, and be able to defend processes, procedures, and decisions during regulatory inspections.