Sr. Manager, R&D Quality

This is a full-time hybrid position (3 days a week) in our Somerville – Assembly Row, Massachusetts office.

SUMMARY 

Manage Quality Approval (qualification) of vendors including R&D, GMP and treatment centers (apheresis collection centers and cell therapy labs) by performing qualification audits and routine (requalification) audits.

Oversee R&D compliance for Genetix clinical studies and Support other Quality Compliance functions, which may include but are not limited to:

• Planning and conducting internal audits
• Assisting with inspection readiness efforts
• Supporting GxP inspection readiness and regulatory inspections

RESPONSIBILITIES

• Collaborate with internal stakeholders (e.g., Apheresis Operations, Commercial, and Clinical Development) and external stakeholders to coordinate and prioritize audits
• Schedule and execute external and internal audits
• Ensure audit observations are communicated, tracked, and remediated in compliance with internal policies and applicable regulatory requirements
• Update approved vendor list, vendor and audit records and develop risk-based audit schedules
• Support annual budget development for outsourced audits
•  Manage Investigator Site Audit Plans for clinical studies
• Develop and present vendor metrics at Management Review
• Oversee R&D quality related activities
• Serve as QA contact for QMS records such as external and internal QMS records and lead investigations, deviations, change controls, and CAPAs, especially those involving CGT clinical operations, analytical activities, or site compliance related
• Serve as compliance lead for clinical studies
• Ensure QA supporting documentation is submitted to the TMF, as applicable
• Serve as QA contact for review and approval of Clinical SOPs
• Perform Regulatory Document Reviews, as applicable
• Provide quality oversight across CGT clinical studies, ensuring GCP compliance, data integrity, and proper documentation throughout clinical execution
• Ensure clinical trial sites are inspection‑ready and provide quality guidance to external partners, CROs, and CGT clinical facilities, ensuring alignment with internal quality standards and regulatory requirements.
• Act as the SME and primary point of contact for inspection management, providing real‑time regulatory guidance.
• Partner with Clinical Operations, Regulatory, and Vendor Management teams to identify and mitigate study specific quality risks throughout the trial lifecycle

QUALIFICATIONS

• 8-10 years of experience in gene therapy/cell therapy/biotech/or other related and regulated industry
• 8–10+ years of experience in R&D Quality
• Experience auditing investigator sites, GMP and R&D vendors and apheresis collection centers and cell therapy labs
• Knowledge of FACT/JACIE requirements
• Demonstrated experience in GCP compliance, clinical trial oversight, inspection readiness, and regulatory interaction
• Direct experience leading clinical deviations, CAPAs, change controls, and investigations
• Experience partnering with Clinical Operations, Regulatory, and cross‑functional stakeholders to manage clinical quality risks

 Preferred Qualifications

• Experience with CGT‑specific clinical QA such as:
• Apheresis and cell handling
• Chain‑of‑custody / chain‑of‑identity systems
• Strong understanding of CGT‑specific analytical and technical quality processes and technical Quality oversight.
• Excellent communication and stakeholder influence skills to support global, cross‑functional clinical programs