Associate Director, Quality Auditing & Compliance

Role: Associate Director, Quality Auditing & Compliance, leading the company’s risk-based internal GxP audit program to ensure adherence to regulatory standards, company policies, and quality systems. Responsibilities: develop and execute audit plans across GxP areas, perform audits of internal and external entities, evaluate compliance with FDA, ICH, and global regulations, and partner with stakeholders on CAPAs and remediation; support inspection readiness and regulatory inspections; contribute to QMS improvements and compliance metrics; monitor industry practices. Requirements: bachelor’s in life sciences, pharmacy, engineering, or related field; 8-10 years in Quality Assurance or Compliance within pharma/biotech, with extensive GxP auditing experience; strong knowledge of FDA, ICH, data integrity, and global regulations; excellent communication skills and ability to influence cross-functional teams; auditor certification preferred. HighValue: GxP audits, FDA and ICH compliance, quality systems, inspection readiness, global regulatory environment, 30-40% travel. WorkSetup: hybrid Waltham, MA or Newark, CA, with domestic and international travel.