Quality Management Specialist - External Supply
Hybrid - South Dublin
18 month contract
AMC4258

This is a hybrid role with about 5% travel to the UK and Europe.

Quality Management Specialist - External Supply - contract oppurtunity

Drive excellence in quality and compliance for our external supply network! As a Quality Management Specialist, you'll be responsible for overseeing and improving the total quality management systems for raw materials, devices, and contract manufacturing. You'll manage nonconformances, CAPAs, change controls, and quality metrics, ensuring adherence to regulations and our high standards.

Key Responsibilities:

• Lead the management and execution of total quality management systems within external supply.
• Manage nonconformances, CAPAs, SICAR, and change controls, and provide oversight of key quality metrics.
• Act as the category owner for all quality records and procedures.
• Investigate deviations, implement corrective actions, and prevent recurrence.
• Communicate effectively across the organization to drive solutions and enable data-driven decision-making.
• Serve as a key liaison between site quality and the corporate Supplier Quality Management team.

• Masters or Bachelor’s degree and 6 years of Quality and/or Manufacturing experience
• Additional years experience will be considered with a lower level qualification

• 6+ years of relevant experience in the biotech or pharmaceutical industry with strong compliance, problem-solving, root cause analysis, and project management skills.
• Deep understanding of quality management systems related to raw materials.
• Expert knowledge of EU and US cGMP regulations.
• Proven ability to work independently, present data clearly, and lead cross-functional teams.
• Proficiency with MS Office Suite and Trackwise.
• Demonstrated negotiation skills.