Associate Principal Quality Partner, Shop Floor

Responsibilities

• Act as a proxy for the team manager as needed, representing QA in operational discussions, prioritization decisions, escalation forums, and cross-functional meetings.
• Complete, review, and approve impact assessments for nonconformances, ensuring robust risk evaluation, sound decision-making, and complete supporting documentation.
• Act as a senior QA approver and governance resource for SOPs, compliance records, NCRs, CAPA plans, effectiveness checks, and other quality system deliverables.
• Provide quality leadership and direction for site projects, compliance initiatives, and cross-functional programs, ensuring quality requirements are embedded early and consistently throughout execution.
• Partner with Production, Supply Chain, Engineering, Operations, and Quality Control leadership to identify systemic risks, influence corrective actions, and prevent recurrence of quality issues.
• Exercise oversight of record completion timeliness and quality, ensuring documentation is complete, accurate, compliant, and aligned with procedural expectations.
• Ensure projects and operational changes are executed in accordance with current Good Manufacturing Practices (cGMP), ISO standards, internal quality policies, and applicable regulatory requirements.
• Lead and/or oversee corrective and preventive action strategies, ensuring effective implementation, sustainability, and measurable improvement in quality performance.
• Provide senior-level support for quality incident investigations, including root cause analysis, risk assessment, resolution planning, and escalation as appropriate.
• Represent Quality Assurance in internal and external audits, inspections, and regulatory interactions as needed, supporting audit readiness, issue resolution, and response coordination.
• Bachelor's Degree required; preferably in Physical or Life Sciences, Pharmacy, or Engineering
• 8+ years of combined experience in Manufacturing, QA, R&D in pharmaceutical, biologics, device or chemical industry
• Must be familiar with use of electronic document management and laboratory information management.
• Must also be familiar with AbbVie Quality Systems as well as cGMP and other regulatory requirements.
• Strong communication Skills, both oral and written
• Preferred
• Experience supporting quality issue resolution, compliance oversight, and cross-functional quality leadership is desired
• Familiarity with electronic document management systems and quality/business systems is desired.
• Demonstrated ability to lead through influence and partner effectively across functions is desired.
• Strong analytical, organizational, and problem-solving skills is desired.
• Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
• We offer a comprehensive package of benefits including

Additional Information

The Associate Principal Quality Partner provides leadership and direction for Quality Assurance activities within Operations and serves as a senior quality resource for assigned functional areas. This role is accountable for driving effective implementation of quality systems, compliance oversight, and sound quality decision-making across the area of responsibility. The position focuses on product and process compliance, issue resolution, quality governance, and strategic quality improvement. This role partners closely with Operations, Manufacturing, Development, Regulatory, and other stakeholders to ensure compliance with AbbVie Quality Systems, cGMP requirements, and applicable regulatory expectations. The role is expected to maintain strong quality performance while driving efficiency, continuous improvement, and effective escalation of quality risks, trends, and systemic issues. The Associate Principal Quality Partner is also expected to proxy for the team manager as needed and provide leadership to cross-functional and team-level strategic initiatives.

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