Quality Assurance Manager

We are seeking an experienced Quality Assurance Manager to lead and oversee all quality systems, regulatory compliance, and audit readiness initiatives. This role is responsible for building, implementing, and maintaining robust quality and safety frameworks that ensure operational excellence, adherence to FDA regulations, and full compliance with GMP (Good Manufacturing Practices) standards.

Key Responsibilities

• Lead and manage company-wide quality and safety programs, ensuring compliance with FDA regulations, GMP, SQF, HACCP, and PCQI standards
• Develop, implement, and continuously improve standard operating procedures (SOPs) and quality systems aligned with regulatory requirements
• Ensure the facility maintains continuous audit readiness for internal, regulatory, and customer audits
• Own and manage the full audit lifecycle: preparation, execution, corrective actions, and follow-up
• Maintain and oversee GMP compliance programs, including sanitation, documentation, and process controls
• Establish and manage compliance documentation systems in accordance with FDA and industry standards
• Partner cross-functionally with operations, supply chain, and leadership to ensure alignment on quality and compliance initiatives
• Drive continuous improvement and lean initiatives to enhance efficiency, reduce risk, and strengthen compliance
• Lead investigations into quality deviations and implement corrective and preventive actions (CAPAs)
• Train and mentor staff on GMP, FDA requirements, and quality procedures

Qualifications

• 5+ years of experience in quality assurance within a regulated environment
• Strong working knowledge of FDA regulations and GMP (Good Manufacturing Practices)
• Experience with SQF, HACCP, and PCQI frameworks
• Proven experience managing internal, regulatory, and customer audits
• Demonstrated ability to build and implement quality systems and SOPs
• Strong understanding of compliance documentation, reporting, and process control
• Excellent leadership, problem-solving, and communication skills
• Experience in a manufacturing or production environment
• Prior experience preparing for and leading FDA inspections