Manager QA

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.
• Support audits and inspections related to the team's areas of responsibility.
• Escalate quality, compliance, supply, and safety risks to senior management.

Basic Qualifications

• High school diploma / GED and 12 years of Quality experience OR Associate's degree and 10 years of Quality experience OR Bachelor's degree and 5 years of Quality experience OR Master's degree and 3 years of Quality experience OR Doctorate degree
• Experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources

Preferred Qualifications

• Experience working in a cGMP environment, with knowledge of quality systems such as deviations, CAPAs, change controls, and material or product disposition
• Ability to interpret procedures and requirements, make sound Quality decisions, and communicate expectations clearly
• Strong collaboration and problem-solving skills, including the ability to work across Quality, Supply Chain, warehouse, Manufacturing, and Quality Control teams
• Ability to manage competing operational priorities while maintaining focus on product quality, compliance, and timely supply
• Experience working in computerized quality systems of record, i.e. Trackwise, SAP, Veeva