Executive Director, Quality Compliance

Role: Senior Quality leader overseeing global GxP compliance and quality systems at a commercial-stage biopharma company. Objectives: provide independent oversight, assurance, and governance of quality frameworks, ensuring inspection readiness and regulatory compliance. Responsibilities: lead the Quality Compliance team, manage risk-based audits (internal, external, third-party), oversee inspection preparedness, manage Quality Risk Management, and govern Quality incident reporting and metrics. Qualifications: Bachelor's in life sciences or related; 15+ years in GxP quality/compliance within biotech or pharma; proven leadership in global compliance programs; strong knowledge of FDA, ICH, and international standards; experience with external manufacturing and regulatory interactions. HighValue: extensive GxP expertise, global audit and inspection oversight, risk management, leadership in commercial biopharma, and ability to operate across external partners. WorkSetup: hybrid Waltham, MA with up to 30% travel.