Aseptic Quality Leader, External Manufacturing

AbbVie; Leinster; On-site; EUR 120,000 - 180,000; Full time

Job summary

AbbVie seeks an Associate Director for Aseptic External & Product Quality Assurance Eye Care Global Team to lead aseptic strategies and ensure robust product quality across external manufacturing networks. The role collaborates with TPMs/CMOs and internal stakeholders to strengthen quality systems and drive continuous improvement.

The ideal candidate has 10+ years in pharma QA operations, deep regulatory inspection experience, and a track record of resolving aseptic quality issues while

Qualifications

• Bachelor’s degree in Life Science or technical field; graduate degree preferred.
• Minimum 10+ years in Quality Assurance Operations Management, Regulatory, Operations or Technical Support in pharma.
• Experience with regulatory inspections and direct interaction with inspectors.
• Plant-level experience in pharmaceutical manufacturing with 5+ years preferred.
• Knowledge of sterile, biologic, and other pharmaceutical technologies.

Responsibilities

• Lead aseptic external quality team and implement aseptic strategies across external partners.
• Perform due diligence visits to TPMs/CMOs and assess aseptic manufacturing operations.
• Provide technical quality leadership for aseptic-related investigations and CAPAs.
• Monitor emerging technologies, regulatory expectations, and industry trends.
• Provide quality oversight to ensure compliance with regulatory requirements and quality standards.
• Support risk-based decision-making for aseptic manufacturing and external quality operations.

Skills

Leadership

Quality assurance

Regulatory

Investigations

Cross-functional

External manufacturing

Education

Bachelor's Life Science

Graduate degree desired

Job description

AbbVie seeks an Associate Director for Aseptic External & Product Quality Assurance Eye Care Global Team to lead aseptic strategies and ensure robust product quality across external manufacturing networks. The role collaborates with TPMs/CMOs and internal stakeholders to strengthen quality systems and drive continuous improvement.

The ideal candidate has 10+ years in pharma QA operations, deep regulatory inspection experience, and a track record of resolving aseptic quality issues while