The Senior Quality Partner is responsible for supporting quality assurance activities on the shop floor, ensuring compliance with Good Manufacturing Practices (GMP), regulatory requirements, and internal AbbVie standards. Acting as subject matter expert, this role collaborates with Production and other key stakeholders in ME&C,Quality, and Operations to resolve quality issues, support data collection and analysis, and drive continuous improvement initiatives. The Senior Quality Partner also supports successful regulatory inspections, fosters cross-functional partnerships, and upholds product quality to meet both customer and regulatory expectations.

Responsibilities

• Serve as the Quality Assurance partner for one or more of the following areas – manufacturing, supply chain, engineering, quality control - overseeing critical stages of the Manufacturing and/or Operations processes to ensure compliance with all applicable GxP standards.
• Review and approve impact assessments for nonconformances, ensuring thorough evaluation and proper documentation.
• Act as QA reviewer and approver for Standard Operating Procedures (SOPs), compliance records, Nonconformance Reports (NCRs), CAPA plans, effectiveness checks, and other quality-related actions.
• Participate as a QA resource for site projects and compliance initiatives, providing quality input in project teams and representing QA in cross-functional settings.
• Collaborate closely with Production, Supply Chain, Engineering, Operations, and Quality Control teams to proactively identify risks, implement corrective actions, and prevent recurrence of issues.
• Oversee and monitor the timeliness of record completion, ensuring all documentation meets quality compliance and procedural requirements.
• Ensure projects are implemented appropriately and promptly, in alignment with current Good Manufacturing Practices (cGMP), ISO standards, and applicable regulations.
• Initiate and drive effective corrective and preventive actions and monitor their implementation to ensure sustained compliance and continuous improvement.
• Support investigations into quality incidents, driving root cause analysis and effective resolution.
• Participate in internal and external audits as required.