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-market quality monitoring, and pharmacovigilance integration as applicable.
 
Cross-Functional Partnership
• Collaborate closely with Clinical, Regulatory Affairs, CMC/Process Development, Manufacturing, Supply Chain, Quality Control, and Commercial teams to integrate quality principles throughout the product lifecycle and enable efficient, compliant decision-making.
• Provide risk-based quality guidance to support regulatory submissions, responses, and commitments while balancing compliance with operational agility in a fast-paced biotech setting.
 
Quality Metrics & Continuous Improvement
• Establish, monitor, and report quality KPIs, trends, risk indicators, and compliance metrics to senior leadership and the Quality Management Review.
• Drive continuous improvement initiatives, including process optimizations, lessons learned from inspections/audits, and enhancements to strengthen compliance maturity, operational efficiency, and inspection outcomes.
• Use data analytics and trending to proactively identify, assess, and mitigate quality risks across the portfolio.
 
People Leadership
• Build, lead, and mentor a high-performing QA and Quality Systems organization; develop talent, succession plans, and training programs to support organizational scaling and commercialization milestones.
• Foster a collaborative, accountable, and inspection-ready mindset across the quality team and broader company.

Requirements

• Bachelor’s degree in Life Sciences, Engineering, Pharmacy, or a related field; advanced degree (e.g., MS, PhD) preferred.
• 12+ years of progressive Quality Assurance experience in pharmaceutical or biotechnology environments, with significant focus on biologics, cell therapies, or advanced therapy medicinal products.
• 7+ years of senior leadership experience with direct ownership and oversight of enterprise Quality Management Systems in a growing organization.
• Hands-on experience supporting late-stage clinical programs, BLA submissions, pre-approval inspections (PAIs), and commercial readiness/launch activities for regenerative medicine or biologics products.
• Deep knowledge of FDA regulations (including 21 CFR Parts 210/211, 820, biologics-specific guidance), GMP, ICH guidelines (Q8-Q12, etc.), and global standards relevant to cell and exosome therapies.
• Demonstrated success leading regulatory inspections (PAIs, routine GMP inspections), responding to findings, and maintaining inspection readiness in dynamic settings.
• Proven ability to scale QMS and quality organizations in a rapidly growing biotech company preparing for commercialization.
• Strong executive presence with the ability to influence, collaborate with, and advise cross-functional teams and senior leadership.
• Excellent communication, problem-solving, decision-making, and strategic thinking skills.

Work Environment / Physical Demands

• Office-based with routine presence in GMP manufacturing and laboratory environments to support oversight, audits, inspections, and quality activities.
• Extended periods of computer use for documentation review, data analysis, metrics reporting, and quality system management.
• Occasional lifting of office or light materials up to 10 pounds.
• Ability to navigate office, laboratory, and GMP manufacturing settings, with occasional travel for inspections, audits, or regulatory meetings as needed.