Quality Assurance Specialist – Third‑Party Laboratory

About the role

The Quality Assurance Specialist provides commercial quality support for AbbVie, focusing on the management of third‑party laboratories that conduct post‑importation testing. The role ensures that all quality activities from receipt of product through distribution comply with corporate, governmental and local regulations.

Key responsibilities

• Integrate local quality regulations for drugs, biologics, devices, combination products and cosmetics.
• Design and implement effective quality systems, procedures and processes across cross‑functional teams.
• Assess compliance with processes, procedures and regulations, identify gaps and drive improvements.
• Plan, prepare, review and approve quality documentation such as change controls and product reviews.
• Support self‑inspections, internal, external and Ministry of Health audits.
• Coordinate investigations of quality events, deviations and non‑conformances and develop corrective action plans.
• Execute supplier qualification and performance monitoring for key suppliers, including third‑party laboratories.
• Manage contracts, statements of work and quality agreements with laboratories.
• Monitor metrics and KPIs to ensure ongoing compliance.
• Support Good Storage and Distribution Practices, including temperature‑controlled and cold‑chain shipments.
• Represent Commercial Quality in cross‑functional projects and manage timelines for post‑importation testing.

Required profile

• Strong knowledge of local quality regulations for pharmaceuticals, biologics, medical devices and cosmetics.
• Experience designing and maintaining quality management systems.
• Proven ability to conduct audits, investigations and CAPA activities.
• Familiarity with supplier qualification processes and contract management.
• Understanding of Good Storage and Distribution Practices and cold‑chain logistics.

Required skills

• Quality management system (QMS) implementation
• Regulatory compliance assessment
• Supplier qualification and performance monitoring
• Audit planning and execution
• CAPA (Corrective and Preventive Action) management
• Cold‑chain and temperature‑controlled logistics oversight