Aseptic Quality Director, External Manufacturing

AbbVie; Dublin; On-site; EUR 120,000 - 160,000; Full time

Job summary

AbbVie in Dublin is seeking an Associate Director focused on Aseptic Product Quality to lead aseptic strategy and quality oversight within the External & Product Quality Assurance Eye Care Global Team. The role drives due diligence with external partners, performs hands-on assessments, and advances best practices across the external manufacturing network.

The incumbent will oversee investigations, risk management, and collaboration with internal sites to strengthen quality systems and ensure

Qualifications

• 10+ years in Quality Assurance Operations Management, Regulatory, Operations, or Technical Support in a pharmaceutical setting.
• Regulatory inspection experience with direct interaction with inspectors.
• Experience working with third‑party external manufacturing.

Responsibilities

• Lead the Aseptic External & Product Quality Assurance Eye Care Global Team by developing and implementing aseptic strategies that ensure robust product quality assurance.
• Conduct due diligence visits to prospective external partners (TPMs/CMOs) as a member of cross-functional teams.
• Perform hands-on assessments of aseptic manufacturing operations, processes, and controls, while driving the implementation and adoption of aseptic best practices across external partners to strengthen quality systems and operational performance.
• Provide technical quality leadership for aseptic-related investigations, including root cause identification, risk evaluation, and the development of corrective and preventive actions.
• Monitor and evaluate emerging technologies, regulatory expectations, and industry trends related to aseptic manufacturing and contamination control.
• Provide quality oversight of external manufacturing operations to ensure compliance with applicable regulatory requirements and quality standards, while proactively identifying, assessing, prioritizing, and mitigating aseptic risks.
• Deliver strategic input and recommendations to support risk-based decision-making for aseptic manufacturing and external quality operations.
• Build and sustain collaborative relationships with AbbVie internal manufacturing sites, global aseptic teams, and cross-functional stakeholders.
• Support the escalation, communication, and resolution of significant aseptic quality issues that may affect product quality or supply continuity.
• Foster and promote a strong quality culture centered on proactive risk management, continuous improvement, product quality, and operational excellence.

Skills

Leadership & cross-functional

Analytical thinking

Problem solving

Communication

Education

Bachelor’s degree in Life Science or related field

Job description

AbbVie in Dublin is seeking an Associate Director focused on Aseptic Product Quality to lead aseptic strategy and quality oversight within the External & Product Quality Assurance Eye Care Global Team. The role drives due diligence with external partners, performs hands-on assessments, and advances best practices across the external manufacturing network.

The incumbent will oversee investigations, risk management, and collaboration with internal sites to strengthen quality systems and ensure