Description

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.

SUMMARY

The Manager, Quality Systems, is responsible for overseeing key elements of the Quality Management System (QMS) that support manufacture, and release of gene therapy products. This role manages the end‑to‑end Complaint and Recall programs, ensures accurate and timely Quality Metrics reporting, drives closure of open quality system records, and supports continuous improvement initiatives and SOP lifecycle management.

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

RESPONSIBILITIES

Oversee intake, triage, investigation, and closure of product quality complaints. Ensure complaint investigations are thorough, scientifically sound, and completed within required timelines.
Manage the recall initiation, assessment, communication, and documentation process in compliance with regulatory expectations. Maintain recall readiness, including procedures, training, and mock recall exercises.
Lead collection, analysis, and reporting of Quality Metrics (e.g., complaint cycle time, deviation aging, CAPA effectiveness)
Lead routine cross‑functional meetings to review and drive timely closure of deviations, CAPAs, change controls, complaints, and other QMS records. Track action items, assign ownership, and ensure adherence to deadlines.
Serve as the QA reviewer/approver of internal quality system records.
Lead and support SOP revisions ensuring clarity, compliance, and alignment with business processes.
Facilitate cross‑functional reviews, training, and implementation of updated procedures.
Support quality improvement initiatives that enhance QMS performance, efficiency, compliance, and data integrity.
Support internal audits and inspections.

QUALIFICATIONS

Bachelor's or Master's degree in Life Sciences, Engineering, or related field.
Minimum 5 years of experience in biotechnology, pharmaceutical, or life sciences industry.
Experience with electronic QMS platforms (e.g., Veeva Vault).
Strong communication, problem‑solving, and cross‑functional leadership skills.

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.

Pay Transparency

$117,000—$166,000 USD

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.

Manager, Quality Systems

Description

Similar Jobs

Like this job? Get alerts for similar ones

Genetix Biotherapeutics

Pipeline

Career Resources