Senior GMP QA Compliance Manager

AbbVie Inc.

Dublin

Hybrid

EUR 100,000 - 140,000

Full time

2 days ago
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Job summary

AbbVie North Dublin seeks a Quality Assurance Compliance Manager to lead the site quality system and ensure GMP conformance across all departments. You will oversee CAPA, change control, document management and training, while preparing key quality documents and reporting to site leadership.

The role requires a strong GMP background, audit/inspection experience, and the ability to drive continuous improvement and QA excellence within a collaborative team.

Qualifications

  • A third-level qualification in a science discipline.
  • Minimum of 8 years' experience in healthcare/pharma.
  • At least 2 years of people management.
  • Demonstrated audit/inspection management experience.
  • Strong understanding of cGMP and manufacturing operations.

Responsibilities

  • Lead site QA compliance program and quality system.
  • Oversee CAPA, Change Management, Document Management, Training and inspections.
  • Ensure GMP compliance across all departments and personnel.
  • Prepare Site Master File, Quality Manual and Quality Plans.
  • Lead regulatory inspections and audits; present data to stakeholders.

Skills

GMP knowledge
Audit & inspection management
People management
Regulatory compliance
Leadership
Communication

Education

Science degree
QP eligibility desirable

Tools

Veeva Vault
TrackWise
ComplianceWire

Job description

AbbVie North Dublin seeks a Quality Assurance Compliance Manager to lead the site quality system and ensure GMP conformance across all departments. You will oversee CAPA, change control, document management and training, while preparing key quality documents and reporting to site leadership.

The role requires a strong GMP background, audit/inspection experience, and the ability to drive continuous improvement and QA excellence within a collaborative team.

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