Quality Compliance Specialist: Drive cGMP Excellence

AbbVie; Sligo; On-site; EUR 60,000 - 90,000; Full time

Job summary

AbbVie is seeking a Quality Compliance Specialist to support and maintain the site’s Quality Management System (QMS) ensuring compliance with AbbVie standards, cGMP requirements, and regulatory guidelines.

You will lead PQR activities, manage technical agreements, and drive QRM across site activities while supporting investigations, CAPA, and supplier quality programs. Strong collaboration with cross-functional teams is required.

Qualifications

• Minimum of 2 years' experience in a GMP environment.
• Knowledge of cGMP requirements and pharmaceutical regulatory expectations.
• Experience with a Quality Management System in a regulated manufacturing environment.
• Strong attention to detail and problem-solving abilities.

Responsibilities

• Coordinate and maintain the site QMS to ensure regulatory compliance.
• Lead and support Product Quality Review (PQR) activities.
• Manage technical agreements, including initiation, review, approval, implementation, and document control.
• Coordinate quality metrics, track-and-trend activities, and performance reporting.
• Drive Quality Risk Management (QRM) principles, including RCS and FMEA processes.
• Support investigations of customer complaints, deviations, and non-conformances with CAPA verification.
• Provide quality oversight for validation activities across systems, processes, and equipment.
• Support New Product Introduction (NPI) projects and collaborate with Manufacturing and Lab functions.
• Monitor quality system performance and present metrics during management reviews.

Skills

Quality management

Regulatory knowledge

Analytical skills

Stakeholder communication

Education

Science/Engineering degree

Tools

QMS software

Job description

AbbVie is seeking a Quality Compliance Specialist to support and maintain the site’s Quality Management System (QMS) ensuring compliance with AbbVie standards, cGMP requirements, and regulatory guidelines.

You will lead PQR activities, manage technical agreements, and drive QRM across site activities while supporting investigations, CAPA, and supplier quality programs. Strong collaboration with cross-functional teams is required.