Provide end-to-end quality systems oversight for Cell & Gene Therapy platforms, ensuring compliance with global GMP and ATMP regulatory requirements
Lead comprehensive review and disposition of deviations impacting Cell & Gene programs, ensuring appropriate impact assessments, risk evaluations, and timely resolution
Drive cross-functional CAPA processes, facilitating structured root cause investigations and ensuring implementation of sustainable, risk-based corrective and preventive actions
Partner with Quality Operations and QISM teams to evaluate system-level trends, identify recurring risks, and strengthen overall quality system effectiveness
Oversee lifecycle management and periodic review of SOPs and controlled documents governing Cell & Gene Therapy platforms to ensure alignment with evolving regulatory guidance
Serve as Quality SME during audits and regulatory inspections, coordinating documentation, responses, and inspection readiness efforts specific to advanced therapy programs
Ensure robust governance of quality system elements critical to Cell & Gene Therapy
Monitor and trend quality metrics to proactively identify compliance gaps and drive continuous improvement initiatives across the platform

Bachelor’s degree in Life Sciences, Biotechnology, Pharmaceutical Sciences, or related field
7+ years of experience in GMP-regulated pharmaceutical or biotechnology environments, with direct experience supporting Cell & Gene Therapy or other advanced biologics programs
Strong expertise in deviation management, CAPA, change control, and quality risk management
Experience supporting regulatory inspections (FDA, EMA, or other global agencies)
Demonstrated ability to collaborate cross-functionally across Quality, Regulatory, Technical Operations, and leadership teams
In-depth understanding of regulatory expectations for advanced therapy quality systems
Ability to be on-site in Boston, MA as needed (potential remote/hybrid work setup
local candidates preferred)

Cell & Gene Therapy Quality Lead

Key skills