Quality Audit Manager

Job Responsibilities

• Oversee internal audits, client audits, and regulatory inspections covering all GMP operations to ensure full compliance with FDA, EMA, ICH, and client requirements.
• Serve as the primary liaison for client audit activities, collaborating with cross‑functional teams and Quality Assurance representatives to address findings, implement corrective actions, and document resolutions.
• Act as the main point of contact for U.S. and international health authority inspections. Coordinate pre‑inspection readiness activities, lead on‑site audit responses, and manage post‑inspection CAPA implementation and communication with regulators.
• Plan, execute, and document internal audits, prepare audit reports, and ensure timely and effective responses to findings.
• Develop and implement process improvements to enhance compliance, efficiency, and effectiveness of the audit program and quality systems.
• Supervise and mentor a small team of audit professionals, providing training, performance feedback, and professional development while ensuring adequate resource allocation for audit and inspection activities.
• Prepare detailed audit reports with risk‑based assessments and corrective action recommendations; maintain audit documentation in compliance with GMP requirements; and deliver regular compliance and performance metrics to senior management.

• Bachelor’s degree in Life Sciences, Engineering, or a related field with in‑depth knowledge of FDA, EMA, and ICH regulations, as well as GMP principles for sterile or pharmaceutical manufacturing operations.
• 7–10 years of experience in the pharmaceutical or biotechnology industry with a focus on quality assurance, auditing, and regulatory compliance.
• At least 3–5 years of supervisory or management experience leading audit or QA teams.
• Direct experience with FDA and/or EMA inspections and a strong understanding of global regulatory requirements, data integrity standards, and computerized systems validation.
• Proven expertise in audit methodologies, risk assessment, CAPA management, and quality management systems within GMP manufacturing environments.