Quality Engineer

About the role

AbbVie is seeking a Quality Engineer to develop, document and maintain a robust quality system at its Ballytivnan site, ensuring compliance with regulatory requirements and company standards.

Key responsibilities

• Maintain strong relationships with the Quality Systems Manager, business unit quality personnel, and customers.
• Coordinate the quality system to ensure full compliance by all personnel.
• Measure quality system performance and report metrics at management review and quality performance meetings.
• Serve as the primary contact for Quality System and Compliance activities, including training, documentation, GDP/Data Integrity, non‑conformance support, internal audit programme maintenance, inspection readiness, and approvals.
• Support inspection readiness by preparing logistics, generating follow‑up responses, and managing CAPA actions.
• Adhere to and promote all EHS standards, procedures, and policies.

Required profile

• Minimum 5 years of experience in quality engineering or a related field within the pharmaceutical/biopharma industry.
• Demonstrated ability to drive quality, compliance and efficiency improvements.
• Strong technical, organizational and people‑management capabilities.
• Commitment to meeting company goals, customer requirements and regulatory obligations (FDA, EU, regional health ministries).

Required skills

• Good Documentation Practices (GDP)
• Data Integrity management
• CAPA (Corrective and Preventive Action) processes
• Internal audit execution and support
• Inspection readiness and support