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.

Qualifications:
• 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.