Ensure that all infant formula products are produced, tested, stored, and released in full compliance with FDA regulations and company standards
Lead daily QA operations and partner closely with Manufacturing, Laboratory, Engineering, and Warehouse teams
Oversee QA activities for infant formula production, including batch record review, product release, and quality system oversight
Ensure compliance with 21 CFR 106/107 and cGMP requirements
Lead investigations, root‑cause analysis, and CAPA for deviations and quality events
Conduct internal audits and support FDA, customer, and corporate audits
Review and approve SOPs, change controls, validation documents, and quality‑critical records
Collaborate with cross‑functional teams to resolve issues and improve product and process performance
Monitor quality metrics and drive continuous improvement initiatives
Train, mentor, and lead QA staff to support a strong quality culture
Serve as a key decision‑maker for product quality and release

Bachelor’s degree in a scientific or technical field
Five years experience in a regulated manufacturing environment; infant formula, food, or pharma preferred
Prior leadership or supervisory experience in QA
Strong understanding of cGMP, FDA regulations, and quality systems
Excellent communication, problem-solving, and decision-making skills.

Quality Assurance Manager

Key skills