Senior QA Manufacturing Compliance Specialist

Senior QA Manufacturing Compliance Specialist

AbbVie

Sligo, Ireland

Job Description

AbbVie Biologics Ballytivnan seeks a Senior Manufacturing Compliance Specialist to strengthen our Quality Assurance operations. In this role, you'll help ensure product excellence through quality compliance, incident resolution, and floor-level support within a collaborative manufacturing environment.

Responsibilities

• Ensure all products and process simulations meet standards for market/investigational use.
• Provide quality guidance and compliance oversight throughout manufacturing.
• Lead or support investigations related to non-compliance in product or processes.
• Mentor, train, and provide support to shift team members.
• Audit batch documentation, review logs, and process SOPs.
• Support and execute line clearance, raw material checks, and stability program activities.
• Manage and maintain finished product status, labeling, and quality logs.
• Conduct daily manufacturing area walkarounds and seek process improvements.
• Support quality aspects of MVI, AQL, and NPI process/material handovers.
• Maintain compliance with cGMP, HPRA/FDA, EHS, and AbbVie standards.

Qualifications

• Third-level degree in science, quality, or engineering.
• Minimum 3 years’ experience in a GMP quality/operations setting (biologics preferred).
• Strong experience in aseptic processing and advanced knowledge of regulatory requirements.
• Excellent written/verbal communication and interpersonal skills.
• Experience as a trainer preferred.
• Demonstrated commitment to quality, problem-solving, and continuous improvement.