Join AbbVie's Quality Assurance team as an MQA Lead at our Biologics facility in Ballytivnan, Sligo. You will play a key role in ensuring that our marketed and investigational drug products meet global standards, providing quality oversight and guidance for aseptic manufacturing operations in a highly regulated environment.

Responsibilities

• Ensure all products meet requirements for patients, regulatory authorities, and the company.
• Provide quality and compliance oversight to operations, supporting aseptic production and intervention observation.
• Lead investigations into product or manufacturing process non-compliance issues.
• Guide, train, and support shift team members in decision-making.
• Review and audit batch records, manufacturing logs, and operational SOPs.
• Perform line clearance, raw material checks, and maintain product status as required.
• Lead GEMBAs of manufacturing areas and drive continuous improvement.
• Act as SME for quality issues during shift operations.
• Uphold all cGMP, HPRA/FDA, and EHS standards.