Aseptic Product Quality Director External Manufacturing

AbbVie Inc.; Dublin; Hybrid; EUR 120,000 - 180,000; Full time

Job summary

AbbVie Inc. in Dublin seeks an Associate Director to lead Aseptic Product Quality within the External & Product Quality Assurance Eye Care Global Team.

This role serves as the quality SME for aseptic manufacturing across external partners, driving continuous improvement and risk mitigation. Reporting to senior leadership, you will guide investigations, ensure regulatory compliance, and foster collaboration with AbbVie sites and TPMs/CMOs to uphold product quality and supply continuity.

Qualifications

• Bachelor’s degree in Life Science or technical discipline.
• 10+ years in Quality Assurance Operations, Regulatory, Operations, or Technical Support in pharma.
• Regulatory inspection experience with direct interaction with inspectors.
• Experience with third-party external manufacturing.

Responsibilities

• Lead the Aseptic External & Product Quality Assurance Eye Care Global Team and develop aseptic strategies.
• Conduct due diligence visits to prospective TPMs/CMOs as part of cross-functional teams.
• Perform hands-on assessments of aseptic manufacturing operations and drive best practices across external partners.
• Provide technical quality leadership for aseptic-related investigations and CAPA development.
• Monitor regulatory expectations and industry trends related to aseptic manufacturing and contamination control.

Skills

Leadership

Analytical thinking

Problem solving

Interpersonal skills

Regulatory awareness

Education

Bachelor’s degree in Life Science or technical discipline

Job description

AbbVie Inc. in Dublin seeks an Associate Director to lead Aseptic Product Quality within the External & Product Quality Assurance Eye Care Global Team.

This role serves as the quality SME for aseptic manufacturing across external partners, driving continuous improvement and risk mitigation. Reporting to senior leadership, you will guide investigations, ensure regulatory compliance, and foster collaboration with AbbVie sites and TPMs/CMOs to uphold product quality and supply continuity.