The Quality Manager is responsible for maintaining and improving the Quality Management System (QMS) to ensure compliance with QA standards, cGMP requirements, and regulatory guidelines. This role works closely with the Director of Quality and cross-functional teams to address compliance issues, oversee quality processes, and ensure product quality and safety.
Manage non-conformance systems, investigations, and corrective actions
Lead and supervise QA/QC staff, ensuring proper training and performance
Collaborate with departments like Operations and Purchasing to improve quality processes
Conduct internal audits and support regulatory compliance efforts
Review and approve batch records, lab documents, and quality-related documentation
Maintain document control systems and quality records
Act as liaison with third-party testing laboratories
Drive continuous improvement and problem-solving initiatives
Bachelor’s degree in a science, engineering, or technical field
3+ years of experience in an FDA-regulated, quality-focused environment
Strong knowledge of cGMP and auditing practices
Excellent leadership, communication, and organizational skills
Strong analytical and problem-solving abilities
ASQ certification preferred
Proficiency in Microsoft Office and ability to manage multiple projects
Ability to stand, sit, or walk for extended periods
Occasional lifting (5–20 lbs) and physical movement (reaching, crouching)
Work in controlled temperature environments (50°F–85°F)
Required PPE: smock, shoe covers, dust mask