Quality Assurance Manager

Quality Assurance Manager- Eau Claire, Wisconsin

The Quality Assurance Manager is responsible for ensuring that all infant formula products are manufactured, tested, stored, and released in full compliance with applicable FDA regulations, cGMP requirements, and company quality standards. This position leads daily QA operations and partners closely with Manufacturing, Laboratory, Engineering, Warehouse, and other cross-functional teams to maintain product safety, quality, compliance, and regulatory readiness.

Key Responsibilities

• Oversee quality assurance activities related to infant formula manufacturing, including batch record review, product disposition and release, and quality systems management.
• Ensure compliance with applicable FDA regulations, including 21 CFR Parts 106 and 107 , cGMP.
• Lead investigations into deviations, nonconformances, complaints, and other quality events.
• Conduct root-cause analyses and develop, implement, and monitor CAPA.
• Conduct internal audits and support FDA, customer, corporate, and other regulatory inspections and audits.
• Review and approve SOPs, change controls, validation and qualification documents, specifications, batch records, and other quality-critical documentation.
• Collaborate with cross-functional teams to resolve quality issues and improve product and process performance.
• Monitor key quality metrics and lead continuous improvement initiatives.
• Train, mentor, and supervise QA personnel while promoting a strong culture of quality and compliance. Serve as a key decision-maker for product quality, disposition, and release.
• Ensure QA records are accurate, complete, timely, and maintained in accordance with company procedures and regulatory requirements.
• Promote a proactive approach to risk management, process control, and ongoing regulatory readiness.

Required Qualifications

• Bachelor’s degree in scientific, technical, food science, pharmaceutical science, or related field.
• At least five years of experience in a regulated manufacturing environment.
• Experience in infant formula, food, pharmaceutical, biotechnology, or a related industry preferred.
• Previous leadership, supervisory, or management experience within a quality assurance function.
• Strong knowledge of cGMP requirements, FDA regulations, quality systems, investigations, CAPA, audits, and change control.
• Familiarity with FDA requirements under 21 CFR Parts 106 and 107 strongly preferred.