AVP - Global ATMP Quality

Role: Global ATMPS (Advanced Therapy Medicinal Products) Quality Leader overseeing Cell and Gene Therapy (CGT) quality from clinical development through commercialization. Responsibilities: lead quality strategy, oversee GMP QA/QC functions for CGT modalities including viral vectors and cell therapies, manage external partnerships, ensure compliance with GQS and GMPs, lead quality system improvements, support regulatory inspections, and build a scalable global QMS. Partner with cross-functional teams such as R&D, manufacturing, regulatory, and external CDMOs; manage quality governance and due diligence for acquisitions; develop and mentor the quality organization. Requirements: bachelor’s in a science field, 15+ years GMP/biotech quality experience, 5+ years leadership, experience with biologics, cell/gene therapy, and regulatory agency interactions; strong judgment, organizational, and communication skills. Preferred: advanced degrees, direct CGT manufacturing experience, technical writing, and global team leadership. High-Value: CGT modalities (AAV, cell therapy, LNP), GMP manufacturing, clinical to commercial phases, regulatory compliance, quality systems, and cross-site leadership. Location: Indianapolis; travel ~15–20% to Lebanon, IN, and external sites.