Associate Director, Sterility & Microbial Contamination Quality

AbbVie; Dublin; On-site; EUR 140,000 - 190,000; Full time

Job summary

AbbVie is seeking an Associate Director of Quality, Microbial Contamination Control to lead sterility assurance and contamination control across its manufacturing network. The role ensures regulatory compliance and drives improvements in aseptic processing and environmental monitoring.

You will provide technical QA expertise, mentor sites, and collaborate with global teams to maintain inspection readiness and robust contamination control programs in line with global GMP guidelines.

Qualifications

• Bachelor/Master degree in Microbiology or related science.
• 7-10 years of experience in pharmaceutical/biopharmaceutical quality.
• Strong knowledge of regulatory requirements (FDA, EMA, EU GMPs, PIC/S).
• Ability to anticipate problems, investigate, and make recommendations.
• Proven history communicating with regulatory agencies.

Responsibilities

• Develop and implement sterility assurance frameworks, including contamination control strategies aligned with Annex I and global GMP guidelines.
• Lead contamination control initiatives to improve aseptic techniques and environmental controls.
• Provide Quality and Compliance guidance to the AbbVie network supporting inspection readiness and sterility assurance.
• Support site regulatory inspections and self-inspection programs.
• Provide aseptic process simulation and environmental monitoring guidance to sites.
• Mentor sites and functional groups on aseptic development and compliance.

Skills

Excellent communication

Problem solving

Regulatory knowledge

Aseptic processing knowledge

Education

Bachelor/Master Degree in Microbiology and/or suitable science qualification

Job description

AbbVie is seeking an Associate Director of Quality, Microbial Contamination Control to lead sterility assurance and contamination control across its manufacturing network. The role ensures regulatory compliance and drives improvements in aseptic processing and environmental monitoring.

You will provide technical QA expertise, mentor sites, and collaborate with global teams to maintain inspection readiness and robust contamination control programs in line with global GMP guidelines.