Associate Director, Quality Auditing & Compliance

Role: Associate Director, Quality Auditing & Compliance, leading risk-based internal GxP audits to ensure regulatory compliance and Quality System effectiveness. Responsibilities: plan and perform audits across GxP areas, evaluate compliance with FDA, ICH, and global standards, develop CAPAs, monitor remediation, support inspection readiness, and contribute to Quality policies and continuous improvement. Requirements: bachelor's in life sciences or related field; 8-10+ years in pharmaceutical/biotech QA, compliance, or auditing; extensive GxP audit experience; strong knowledge of FDA regulations, data integrity, and quality systems; demonstrated risk assessment and remediation skills; ability to lead and influence cross-functionally; willingness to travel 30-40%. Preferred: advanced degree, professional auditor certification. High-value: focus on GxP compliance, regulatory inspections, risk management, and quality assurance within biopharma. Work setup: hybrid (2-3 days onsite in Waltham, MA or Newark, CA).