Senior Director, Quality Assurance & Quality Systems

Responsibilities

• 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.