Executive Director, External Operations Quality

Role: Executive Director, External Operations Quality, providing strategic and operational leadership for quality oversight of Ardelyx’s external manufacturing network. Responsibilities: oversee compliance, product quality, and supply reliability across CMOs, testing labs, and packaging partners; lead quality governance, issue escalation, performance monitoring, and risk management; manage quality agreements, change controls, investigations, and CAPAs; support technology transfers, validation, and regulatory inspections; monitor quality metrics and continuous improvement initiatives. Requirements: Bachelor's in life sciences, engineering, pharmacy, or related field; 15+ years in GxP quality or compliance within biotech/pharma; significant leadership in commercial-stage organizations; deep knowledge of global GxP regulations, FDA, ICH, and international standards; experience managing external manufacturing compliance, audits, and risk. Preferred: experience in biopharma quality leadership, global compliance programs, and managing quality for biologics or other modalities. High-Value: extensive external partner oversight, manufacturing quality governance, regulatory inspection readiness, and global GxP expertise. WorkSetup: hybrid (Waltham, MA or Newark, CA), with up to 25% domestic and international travel.