The Quality Compliance Specialist is responsible for supporting and maintaining the site's Quality Management System (QMS) to ensure compliance with AbbVie standards, cGMP requirements, and applicable regulatory guidelines. The role plays a key part in ensuring that products manufactured at AbbVie consistently meet the expectations of patients, regulatory authorities, and the company.

Key Responsibilities

• Coordinate and maintain the site Quality Management System, ensuring compliance with AbbVie policies and applicable regulatory requirements.
• Lead and support Product Quality Review (PQR) activities.
• Manage technical agreements, including initiation, review, approval, implementation, and document control.
• Coordinate quality metrics, track-and-trend activities, and performance reporting to support Manufacturing and Quality Control operations.
• Drive the application of Quality Risk Management (QRM) principles across site activities, including Risk Control Strategies (RCS) and FMEA processes.
• Support investigations of customer complaints, deviations, and non-conformances, ensuring robust CAPA implementation and effectiveness verification.
• Provide quality oversight and approval for validation activities, including systems, processes, and equipment.
• Support New Product Introduction (NPI) projects and collaborate closely with Manufacturing, Technical Operations, and Laboratory functions.
• Monitor quality system performance and present key metrics during management review and site performance meetings.
• Coordinate change control activities and assess quality impact associated with proposed changes.
• Provide guidance to site personnel on cGMP, quality system requirements, and regulatory expectations.
• Act as a key liaison with corporate quality functions and regulatory agencies, including HPRA, FDA, and other regulatory authorities.
• Perform regulatory assessments and policy reviews to ensure ongoing compliance.
• Initiate and manage quality event records, investigations, and CAPA activities as required.
• Support supplier quality activities, including vendor qualification, supplier performance monitoring, notifications, and audits.
• Participate in and support internal audits, regulatory inspections, customer audits, and inspection readiness activities, including audit responses and evidence management.
• Contribute to continuous improvement and compliance initiatives across the site.
• Ensure adherence to all Environmental, Health & Safety (EHS) standards, procedures, and policies.