Quality Assurance Manager

A growing regulated manufacturing company is seeking an experienced Quality Assurance Manager to lead its quality systems and support the organization's continued growth toward pharmaceutical-grade manufacturing.

This is a highly visible, hands‑on leadership opportunity for a quality professional who thrives in both the manufacturing environment and laboratory. The ideal candidate will take ownership of the site's Quality Management System, ensure cGMP compliance, oversee product release activities, and partner with operations to drive continuous improvement.

• Lead and continuously improve the site's cGMP Quality Management System (QMS)
• Manage SOPs, CAPA, investigations, audits, document control, training, and compliance programs
• Oversee analytical laboratory operations, including HPLC testing and third‑party laboratory coordination
• Review Certificates of Analysis (COAs), analytical data, specifications, and manufacturing records
• Approve or reject raw materials, intermediates, and finished products
• Lead customer and regulatory audits while maintaining inspection readiness
• Support development of pharmaceutical/API quality systems and regulatory compliance
• Partner with Operations, Engineering, R&D, Maintenance, and Executive Leadership to improve quality performance
• Manage sanitation programs and lead a small quality team
• Investigate quality issues, deviations, nonconforming materials, and customer complaints while driving corrective actions

• Bachelor's degree in Chemistry, Biology, Microbiology, Food Science, Engineering, Pharmaceutical Science, or related technical field (or equivalent experience)
• 5+ years of Quality Assurance or Quality Systems experience within a regulated manufacturing environment
• Strong experience with cGMP compliance, CAPA, audits, investigations, SOPs, document control, and product disposition
• Experience supporting manufacturing operations in a production environment
• Excellent analytical, organizational, and communication skills

• Pharmaceutical, API, biotechnology, dietary supplement, food ingredient, or specialty chemical manufacturing
• HPLC laboratory oversight or analytical testing experience
• Validation, data integrity, supplier qualification, or electronic Quality Management Systems (eQMS)
• Experience building or improving quality systems within a growing manufacturing organization

• Opportunity to make a significant impact within a growing organization
• High visibility with executive leadership
• Play a key role in advancing pharmaceutical-grade manufacturing capabilities
• Competitive compensation and long‑term career growth