Verista, Inc.

Cell & Gene Therapy Quality Lead

Verista, Inc.

full-time

Posted on:

Location Type: Hybrid

Location: Boston • Massachusetts • United States

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Salary

💰 $85,000 - $127,144 per year

Job Level

Senior

About the role

  • 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

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)
Benefits
  • Competitive pay plus performance-based incentive programs
  • Company-paid Life, Short-Term, and Long-Term Disability Insurance.
  • Medical, Dental & Vision insurances
  • FSA, DCARE, Commuter Benefits
  • Supplemental Life, Hospital, Critical Illness and Legal Insurance
  • Health Savings Account
  • 401(k) Retirement Plan (Employer Matching benefit)
  • Paid Time Off (Rollover Option) and Holidays
  • As Needed Sick Time
  • Tuition Reimbursement
  • Team Social Activities (We have fun!)
  • Employee Recognition
  • Employee Referral Program
  • Paid Parental Leave and Bereavement
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
GMPATMPdeviation managementCAPAchange controlquality risk managementregulatory inspectionsquality metricsSOP managementquality system governance
Soft Skills
collaborationleadershipcommunicationproblem-solvingrisk evaluationimpact assessmentcross-functional teamworkcontinuous improvementstructured investigationsaudit readiness