Senior Associate Director, Microbial Contamination Control

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

Job summary

AbbVie Inc. is seeking an Associate Director of Quality, Microbial Contamination Control to lead sterility assurance and contamination control programs across AbbVie sites and external manufacturers.

The role provides technical quality oversight, drives improvements, and ensures compliance with current regulatory requirements for aseptic processing and sterile manufacturing operations.

Qualifications

• Bachelor/Master Degree in Microbiology and/or suitable science qualification.
• Minimum 7-10 years relevant experience and aseptic process knowledge within Pharmaceutical and/or Biopharmaceutical industry.
• Knowledge of Pharmaceutical Regulatory Requirements and expectations including CFR, EU GMPs, EMA/FDA Guidelines, Pharmacopeia, PIC/S.
• Ability to anticipate problems, identify and investigate them, and make recommendations to help resolve.
• Proven history of implementing innovative approaches.
• Demonstrated ability to interface with multiple regulatory agencies.
• Ability to evaluate quality, production and support areas for GMP compliance.
• Excellent communication skills both verbally and written.

Responsibilities

• Develop sterility assurance frameworks aligned with Annex I and global GMP guidelines.
• Provide quality and compliance guidance to sites for inspection readiness.
• Lead contamination control initiatives to improve aseptic techniques and environmental controls.
• Support Site regulatory inspections and self-inspection programs.
• Provide aseptic subject matter expertise to external manufacturing QA and auditing programs.
• Assess the AbbVie Quality System for regulatory alignment.
• Member of AbbVie Centers of Excellence for Contamination Control and Microbiology laboratories.
• Develop environmental monitoring programs and trending processes for critical data.

Skills

Quality Assurance

Regulatory Liaison

Problem Solving

Communication

Education

Bachelor/Master Degree in Microbiology

Job description

AbbVie Inc. is seeking an Associate Director of Quality, Microbial Contamination Control to lead sterility assurance and contamination control programs across AbbVie sites and external manufacturers.

The role provides technical quality oversight, drives improvements, and ensures compliance with current regulatory requirements for aseptic processing and sterile manufacturing operations.