Senior Director, Quality

Responsibilities

The Senior Director, Quality will provide strategic vision and operational direction for the Quality organization to ensure all programs meet the highest standards of safety, efficacy, and regulatory compliance.

 
Quality Strategy & Leadership
• Define and execute the enterprise quality strategy aligned with late-stage clinical development, BLA/regulatory submissions, potential commercial launch, and post-approval lifecycle management for cell and exosome-based therapies.
• Serve as the senior Quality leader and strategic advisor to executive and operations management on compliance matters, inspection readiness, quality risk management, and GxP expectations in a biotech environment.
• Establish and reinforce a strong quality culture emphasizing accountability, data integrity, continuous improvement, and risk-based decision-making throughout the organization.
 
Enterprise Quality Systems
• Own and continuously enhance the enterprise QMS to support clinical, manufacturing, and commercial operations, including Document Control and Change Management, Deviations/Investigations/CAPA, Training and Qualification, Data Integrity and Records Management, and other core quality processes.
• Ensure quality systems are phase-appropriate, scalable, efficient, and fully aligned with FDA GMP regulations (21 CFR Parts 210/211, 820, and biologics-specific guidance), ICH guidelines, ISO standards, and global expectations for advanced therapies.
• Lead QMS readiness and optimization for commercialization, pre-approval inspections (PAIs), post-approval commitments, and lifecycle management of Deramiocel and future products.
 
Regulatory Compliance & Inspection Readiness
• Ensure ongoing compliance with FDA, GMP, and applicable global regulations for clinical trials, manufacturing, and potential commercial activities, including cell therapy and exosome platforms.
• Lead preparation for, management of, and response to regulatory inspections (including PAIs), partner audits, and health authority interactions; act as the primary Quality representative during agency engagements and inspections.
• Support quality-related aspects of regulatory submissions, responses to information requests, and commitments (e.g., contributing to BLA updates addressing any quality/CMC items).
 
Clinical, Manufacturing & Commercial Quality Oversight
• Provide comprehensive quality oversight for clinical quality assurance, including GCP compliance and support for ongoing trials such as HOPE-3 extensions or related activities.
• Oversee quality support for manufacturing, testing, process validation, technology transfer, comparability studies, and supply chain activities for late-stage and commercial products (e.g., Deramiocel cell therapy production).
• Ensure timely and effective resolution of quality events, deviations, CAPAs, complaints, and out-of-specification results, with appropriate escalation, root cause analysis, and management visibility.
• Support commercial readiness activities, including product release processes, distribution oversight, post-marke