GMP & Regulatory QA Compliance Leader

AbbVie; Dublin; On-site; EUR 90,000 - 130,000; Full time

Job summary

AbbVie North Dublin is seeking a Quality Assurance Compliance Manager to lead the site’s quality system, ensuring GMP compliance across all departments and personnel. You will provide technical leadership, support inspection readiness and act as a quality systems SME for the site.

You will manage a team of quality professionals, develop quality plans, and liaise with the FDA, HPRA and other regulators to ensure product safety and compliance.

Qualifications

• Third-level qualification in a science discipline with at least 8 years' experience in healthcare or pharmaceutical industry.
• Two years of people management experience.
• Demonstrated audit and inspection management experience.
• Excellent understanding of current Good Manufacturing Practice (cGMP) and manufacturing operations.
• QP eligibility is desirable.

Responsibilities

• Lead QA aspects of the site quality system including CAPA, Change Management, Document Management, and inspections.
• 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.

Skills

Audit & inspection management

cGMP knowledge

Quality systems

Microsoft Office

Veeva Vault

TrackWise

ComplianceWire

Education

Science degree (third-level)

QP eligibility (desirable)

Tools

Microsoft Office

Veeva Vault

TrackWise

ComplianceWire

Job description

AbbVie North Dublin is seeking a Quality Assurance Compliance Manager to lead the site’s quality system, ensuring GMP compliance across all departments and personnel. You will provide technical leadership, support inspection readiness and act as a quality systems SME for the site.

You will manage a team of quality professionals, develop quality plans, and liaise with the FDA, HPRA and other regulators to ensure product safety and compliance.