Sr. Manager, R&D Quality
About this role
About Genetix Biotherapeutics
At Genetix Biotherapeutics every role has meaning, every team member is respected, and every day is a chance to make a difference. When you join Genetix, you're not just landing a new role, you become part of a company that's pursuing curative gene therapies to give patients and their families more days. We are doers, thinkers and collaborators who embrace and live by our values:
Our innovation is rooted in the diversity of our teams and results are achieved through cooperation and the integration of multiple viewpoints. This is personal and we approach every challenge with radical care.
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
Additional Information
The pay transparency range provided below is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. We may ultimately pay more or less than the posted range, and the range may be modified in the future. This role is eligible for an annual bonus and long-term incentive. Actual base salary pay will be based on several factors, including but not limited to experience, skills, relevant education/qualifications, external market, internal equity, and other job-related factors permitted by law.
Genetix’s total rewards package also provides employees with a comprehensive and competitive benefits suite to support a variety of employee needs. These benefits include comprehensive health, life and disability insurance, employer-matched 401(k) plan, lifestyle spending account, flexible time-off + paid holidays and winter holiday period, tuition reimbursement & loan repayment assistance, paid parental leave, paid onsite parking, commuter subsidy, and much more.
Genetix is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status or any other applicable legally protected characteristics.
Frequently Asked Questions
Is the salary disclosed for the Sr. Manager, R&D Quality position at genetixbiotherapeutics?
Where is the Sr. Manager, R&D Quality position at genetixbiotherapeutics located?
Which team or department does the Sr. Manager, R&D Quality at genetixbiotherapeutics belong to?
How do I apply for the Sr. Manager, R&D Quality position at genetixbiotherapeutics?
When was the Sr. Manager, R&D Quality job at genetixbiotherapeutics posted?
You'll be redirected to genetixbiotherapeutics's official application page on Greenhouse.