Manager QA

About This Role

Managing Quality Assurance teams responsible for Incoming Quality, Raw Material and Product Disposition, and Quality oversight of Warehouse operations is the core of this role. The team supports the inspection, sampling, and testing of incoming raw materials and components, makes disposition decisions for raw materials and product, and provides Quality oversight of ARI warehouse operations. This position involves working broadly across the site and with network partners to resolve issues and influence process improvements, while also hiring, developing, and leading Quality professionals.

Responsibilities

• Lead and empower teams responsible for Incoming Quality, Raw Material and Product Disposition, and warehouse Quality oversight
• Oversee incoming material inspection, sampling, testing, documentation review, disposition and related Quality activities
• Ensure raw material and product disposition decisions are timely, well documented, risk based, and consistent with approved procedures
• Monitor key metrics across Incoming Quality and disposition to assess process health, identify trends, and lead improvement actions
• Provide Quality oversight of warehouse operations, including receiving, material status control, storage, handling, dock activities, and shipping
• Oversee the Raw Material Reject Cage and ensure rejected materials are appropriately controlled and managed
• Provide Quality guidance for deviations and change controls, including assessment of potential impact to product quality, compliance, and supply
• Lead resolution of impactful events using risk-based judgment, balanced thinking, and cross-functional collaboration
• Review and approve cGMP processes, procedures, documents, and records, including nonconformances, deviations, CAPAs, change controls, validations, and raw material and drug substance documentation
• Ensure changes that could affect product quality or compliance are assessed and managed in accordance with applicable procedures
• Develop team capability through hiring, onboarding, training, coaching, and performance management
• Communicate team goals, priorities, and performance expectations; coordinate actions to improve team and overall QA performance
• Develop or contribute to procedures, standards, and operating practices that support consistent and compliant execution
• Facilitate continuous improvement at the site and network levels across Incoming Quality, disposition, and warehouse quality processes
• Represent QA on site, project, and network teams, including the global disposition network, and contribute to process direction and improvement
• Partner with Supply Chain, Manufacturing, Quality Control, warehouse teams, and other stakeholders to resolve issues, establish direction, and support compliant and timely operations