Executive Director, External Operations Quality

Role: Senior leader overseeing external manufacturing quality for a biopharma company, ensuring external partners meet regulatory and quality standards. Responsibilities: manage quality governance, perform risk assessments, oversee change controls, deviations, and investigations; lead technology transfers, analytical method validation, and supplier qualification; monitor external partner performance, conduct audits, and prepare for inspections; develop and mentor the External Operations Quality team. Requirements: Bachelor's in life sciences, engineering, pharmacy, or related field; 15+ years in GxP quality/compliance within biotech/pharma, with significant leadership experience in a commercial-stage organization; deep knowledge of global GxP regulations (FDA, ICH); experience with quality events, recalls, and data integrity; strong influencing skills and strategic leadership. HighValue: external manufacturing oversight, GxP compliance, regulatory inspections, risk management, leadership of global compliance programs. WorkSetup: hybrid Waltham, MA or Newark, CA, with up to 25% travel.