Quality Lab Supervisor

Quality Lab Supervisor

The Quality Assurance Manager leads and maintains the Quality Management System (QMS) to ensure cosmetic, personal care, and OTC products comply with FDA regulations, cGMP requirements, and applicable ISO standards. This role provides quality oversight for manufacturing operations, supports audits and inspections, and drives continuous improvement to ensure product quality and compliance.

Key Responsibilities

• Manage and improve the QMS, including deviations, CAPAs, change controls, nonconformances, and document control.
• Establish and monitor quality metrics to assess compliance and performance.
• Lead and support FDA inspections, customer audits, and third-party audits; ensure timely completion of corrective actions.
• Provide QA oversight for manufacturing, packaging, labeling, warehousing, and distribution operations.
• Review and approve quality documentation, investigations, batch records, and specifications.
• Support validation, supplier quality, and material qualification programs.
• Serve as the primary quality contact for customers and manage complaints, investigations, and CAPAs.
• Partner with Operations, Regulatory, Supply Chain, and R&D to ensure product quality and GMP compliance.
• Lead, mentor, and develop QA personnel while promoting a culture of quality and continuous improvement.

Qualifications

Education

• Bachelor's degree in a scientific discipline required; advanced degree preferred.

Experience

• 5+ years of QA experience in cosmetics, personal care, OTC, pharmaceutical, or regulated manufacturing environments.
• Prior QA leadership or supervisory experience required.
• Experience managing audits, inspections, investigations, and quality systems.

Knowledge & Skills

• Strong knowledge of FDA regulations, cGMPs, ISO standards, and cosmetic/OTC compliance requirements.
• Experience with CAPA, change control, complaint management, and root cause investigations.
• Familiarity with validation, supplier quality, and quality risk management.
• Strong leadership, communication, organizational, and problem-solving skills.
• Proficiency in Microsoft Office and electronic quality management systems (eQMS) preferred.

Preferred

• Experience supporting FDA inspections and customer audits.
• Knowledge of ISO 22716, ISO 9001, and OTC manufacturing requirements.
• Lean Manufacturing and/or Six Sigma experience a plus