6215 - Cell & Gene Therapy Quality Lead / Sr. Quality Lead

Verista, Inc.•Boston, MA

2d•Hybrid

About The Position

Verista’s 500 experts team up with the world’s most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world’s most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision-making and are the result of our significant investment in our people and our capabilities. Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day. Company Culture Guidelines & Values: We empower and support our colleagues We commit to client success at every turn We have the courage to do the right thing We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged. We constantly acquire new skills and learn from our experiences to enhance our collective expertise

Requirements

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)

Responsibilities

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