Purpose

The Senior Lead, Supplier Quality Assurance serves as the primary supplier quality representative supporting APL operations and is the Supplier Quality point of contact for the site. This position is responsible for ensuring supplier quality systems, processes, and supplier-related activities align with site requirements, regulatory expectations, and AbbVie quality standards. The Senior Lead is expected to exercise strong independent judgment, lead supplier quality initiatives, and proactively drive issue resolution, risk mitigation, and continuous improvement in support of site operations.

Responsibilities

• Implements and maintains Quality System.
• Ensures alignment of practices and procedures with policies and regulations.
• Serve as the primary Supplier Quality representative supporting APL operations and act as the owner of the approved supplier list, including material, service, and supplier qualification, performance, and discontinuation.
• Provide leadership and direction for day-to-day supplier quality support, including incoming materials, supplier issue resolution, and oversight of supplier-related quality activities.
• Partner with APL operations, quality, procurement, planning, manufacturing, and other cross-functional teams to support uninterrupted site operations and maintain effective internal and global relationships.
• Lead supplier quality investigations, escalations, containment actions, and follow-up activities to ensure timely and effective resolution of supplier-related quality events.
• Review, assess, and disposition supplier-related quality events, complaints, deviations, nonconformances, and related quality documentation as applicable.
• Drive supplier performance monitoring through quality metrics, trend analysis, and periodic business reviews.
• Lead supplier qualification, requalification, audits, and ongoing oversight activities.
• Evaluate supplier corrective and preventive actions (CAPAs) and verify effectiveness where required.
• Identify, communicate, and mitigate supplier quality risks; support change control and new product introduction activities; ensure compliance with regulatory requirements, internal procedures, and quality system expectations; and resolve issues affecting material availability, product quality, and supply continuity.
• Escalate critical supplier quality concerns to site leadership, provide subject matter expertise, contribute to continuous improvement initiatives, and lead with minimal oversight through strong accountability, sound decision-making, and independent prioritization.