Manager, Quality Systems - CAPA Inspection Management

Overview

Job Summary

The Manager, Quality Systems - CAPA & Inspection Management leads the Norcross site end-to-end qual-ity event/CAPA governance and inspection-management processes within Quality Systems & Compliance. The role provides management oversight of Quality System personnel responsible for event/CAPA review and approval and establishes consistent governance from Phase 1 event definition (EDF) through Phase 2 root cause investigation (RCI), corrective/preventive action, effectiveness verification, and closure.

The Manager also leads site Quality System oversight through quality metrics, Quality System Management Review (QSMR), internal and external audit readiness, and regulatory/notified-body inspection manage‑ment. This role partners across Quality and Operations to ensure issues are risk-assessed, investigated to appropriate depth, actions are sustainable and effective, systemic trends are identified, and the site main‑tains a state of inspection readiness.

Key Accountabilities

• Lead, coach, mentor, and develop Quality Systems personnel responsible for event/CAPA review and approval, inspection readiness, audit support, and assigned Quality System activities; establish stand‑ard work, workload priorities, backup coverage, and performance expectations.
• Lead day-to-day governance of the end-to-end Event/CAPA process, including Phase 1 Event Definition (EDF), Phase 2 Root Cause Investigation (RCI), corrective/preventive action planning, implemen‑tion, effectiveness verification, and closure.
• Establish and maintain clear, risk‑based standards and approval criteria for event classification, prob‑lem definition, investigation depth, root cause determination, CAPA adequacy, due‑date management, extensions, and effectiveness checks.
• Ensure Quality System approvers provide independent, timely, consistent, and compliant review and approval of events, investigations, CAPAs, extensions, and effectiveness evidence.
• Monitor Event/CAPA performance through meaningful metrics, including aging, overdue records, cycle time, recurrence, right‑first‑time approval, extensions, and effectiveness failures; identify sys‑temic trends and elevate significant compliance risk.
• Lead site inspection management and readiness, including inspection plans, front‑room/back‑room coordination, SME preparation, request tracking, response governance, observation management, mock inspections, and post‑inspection follow‑up.
• Plan and coordinate internal audits and support regulatory/notified‑body and customer inspections in partnership with process owners and applicable Corporate/Global Quality functions; ensure resulting commitments are governed, completed on time, and evaluated for effectiveness.
• Own or coordinate Quality System performance metrics and QSMR inputs, ensuring data are accurate, risk‑based, appropriately trended, and translated into clear management actions and follow‑up.
• Partner with Manufacturing QA, Laboratory Services, Post‑Market Surveillance, Design & Sustaining Quality Engineering, Regulatory Affairs, Manufacturing, Supply Chain, and other process owners to ensure Quality events, CAPAs, audits, and inspection commitments are appropriately owned and re‑solved.
• Provide Quality System expertise and interpretation of applicable FDA, ISO 13485, MDSAP, EU IVDR, and internal Quality requirements while fostering patient safety, compliance, right‑first‑time execution, transparency, accountability, and continuous improvement.
• Performs other duties and responsibilities as assigned

Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.

Networking/Key relationships

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