Supplier Quality Auditor

Job Summary

The Supplier Quality Auditor is responsible for executing risk-based GMP audit programs supporting OTC and cosmetic operations. They will ensure compliance with 21 CFR 210/211, ISO 22716, and internal quality systems. They will lead supplier, CMO, and internal audits, including routine, for-cause, and surveillance activities. They will support inspection readiness and continuous improvement activities.

Responsibilities

• Execute risk-based GMP audits (supplier, CMO, internal, for-cause, surveillance).
• Perform gap assessments and compliance evaluations aligned with regulatory standards.
• Identify, document, and assess audit findings with appropriate risk ratings.
• Drive and track CAPA, SCAR, and deviation resolution.
• Support inspection readiness, including mock audits and audit hosting activities.
• Provide cross-functional GMP and quality compliance support.
• Support change control, document control, and training processes.
• Ensure compliance with QMS requirements.
• Understand tracking and trending data for Quality Compliance.
• Analyze and trend quality data to support continuous improvement.

Qualifications

• Bachelor’s degree & 3-5 years’ directly related experience, or an equivalent combination of education and experience.
• Travel up to 50%.
• 3-5 years’ GMP Quality/Auditing experience (OTC, cosmetic, or pharmaceutical).
• Strong knowledge of GMP regulations and quality systems.
• Effective audit execution and technical writing skills.
• Strong analytical and problem-solving abilities.
• Excellent communication and cross-functional collaboration skills.