QA Compliance Leader – GMP, CAPA & Inspections

AbbVie; Dublin; On-site; EUR 90,000 - 120,000; Full time

Job summary

AbbVie North Dublin is seeking a Quality Assurance Compliance Manager to lead the development and maintenance of the quality system, ensuring GMP compliance and readiness for regulatory inspections. You will guide a team of quality professionals and act as a SME for site quality systems.

The role includes oversight of CAPA, Change Management, training, supplier management, and continued improvement initiatives, including adoption of AI-enabled tools.

Qualifications

• Third-level qualification in a science discipline.
• At least 8 years in healthcare or pharmaceutical industry.
• Two+ years people management experience.
• Demonstrated audit and inspection management experience.
• Excellent understanding of cGMP and manufacturing operations.

Responsibilities

• Lead the QA aspects of the site quality system including CAPA, Change Management, Document Management, Complaints, Training, Inspection Readiness, and Management reviews.
• Develop and manage the quality system to ensure compliance with US FDA, ICH, EudraLex and AbbVie requirements.
• Prepare and maintain the Site Master File, Quality Manual and Quality Plans.
• Lead regulatory inspection and corporate audit preparation for the assigned area and report quality performance to site leadership.
• Champion AI-enabled tools to drive process optimisation and continuous improvement.

Skills

Leadership

Quality mindset

Problem-solving

Communication

Attention to detail

Education

Science degree

Tools

Veeva Vault

TrackWise

ComplianceWire

Microsoft Office

Job description

AbbVie North Dublin is seeking a Quality Assurance Compliance Manager to lead the development and maintenance of the quality system, ensuring GMP compliance and readiness for regulatory inspections. You will guide a team of quality professionals and act as a SME for site quality systems.

The role includes oversight of CAPA, Change Management, training, supplier management, and continued improvement initiatives, including adoption of AI-enabled tools.