AI-Driven QA Compliance Leader (GMP, Inspections)

ABBVIE; Dublin; Sur place; EUR 110 000 - 140 000; Plein temps

Résumé du poste

AbbVie North Dublin seeks a Quality Assurance Compliance Manager to lead the site quality system, ensure GMP compliance and support readiness for regulatory inspections. You will guide CAPA, document management, training and supplier quality, partnering with cross-functional teams.

This leadership role requires a science degree with 8+ years in healthcare or pharma, and at least 2 years of people management; QP eligibility is desirable.

Qualifications

• A third-level qualification in a science discipline and at least 8 years' experience in the healthcare or pharmaceutical industry.
• A minimum of two years of people management experience.
• Demonstrated audit and inspection management experience.
• Excellent understanding of current Good Manufacturing Practice (cGMP) and manufacturing operations.

Responsabilités

• Lead the Quality Assurance aspects of the site quality system, including Management Review, CAPA, Change Management, Document Management, Complaints, Training, Inspection Readiness and Management.
• Develop and manage the quality system to ensure compliance across all departments and personnel with US FDA, ICH, EudraLex and AbbVie requirements and standards.
• Prepare and maintain the Site Master File, Quality Manual and Quality Plans.
• Lead regulatory inspection and corporate audit preparation for the assigned area and escalate significant quality events to site leadership.
• Identify and lead continuous improvement and simplification initiatives, including new quality systems initiatives.

Connaissances

Leadership

Audits & inspections

cGMP knowledge

Regulatory liaison

Documentation

Formation

Science degree

Outils

Veeva Vault

TrackWise

ComplianceWire

Description du poste

AbbVie North Dublin seeks a Quality Assurance Compliance Manager to lead the site quality system, ensure GMP compliance and support readiness for regulatory inspections. You will guide CAPA, document management, training and supplier quality, partnering with cross-functional teams.

This leadership role requires a science degree with 8+ years in healthcare or pharma, and at least 2 years of people management; QP eligibility is desirable.