Sr Program Manager
Core
Lead Deviation, CAPA, and Change Control programs to ensure compliance with regulatory requirements and quality standards in a cell therapy manufacturing facility.
Role type
Senior Program Manager (Quality Systems & Compliance)
Builds
Commercial-scale CGMP manufacturing of autologous and allogeneic cell therapies
Domain
Biopharmaceuticals / Cell & Gene Therapy
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Project management, CAPA management, root cause analysis, regulatory compliance, cross-functional team leadership, quality metrics monitoring
Preferred skills
Biologics fermentation, cell culture, purification, analytics, commercial program management
Technologies
CGMP manufacturing systems, quality management software
Responsibilities
Lead and oversee Deviation, CAPA, and Change Control programs; Manage the full lifecycle of investigations and change controls; Serve as Subject Matter Expert for Quality Systems; Monitor quality metrics and drive process improvements; Support regulatory inspections and customer audits
Seniority
Senior, hands-on IC
