A Senior Associate Quality Operations is required to join a global biotech company based in Limerick. This role will be fully on site in a brand new start of the art manufacturing facility and will play a critical role in maintaining the quality and regulatory compliance of biopharmaceutical products.


The role

• Work closely with cross-functional teams to implement and uphold quality assurance standards, facilitate inspections and audits, and support continuous improvement initiatives.
• Develop and maintain quality assurance procedures, policies, and systems
• Conduct routine self-inspections and monitoring assessments (time-on-the-floor) to ensure compliance with cGMP (current Good Manufacturing Practices) and other relevant regulations
• Investigate and address deviations, non-conformities, and CAPA (Corrective and Preventive Actions) to maintain product quality
• Maintain accurate and comprehensive quality records, including batch records, change control documentation, and quality reports

• BSc Hons, MSc, or PhD in Pharmacy, Science, Engineering, Quality, or related discipline
• Minimum of 5 years of experience in quality assurance within a biotechnology or pharmaceutical manufacturing environment
• Strong knowledge of cGMP, FDA, Data Integrity, Quality Risk Management and other biopharmaceutical regulatory requirements
• Experience with quality management systems (e.g., TrackWise, MES) is a plus