---
title: 'Sr. Manager, Quality Assurance for Quality Control at Genetix Biotherapeutics'
canonical: 'https://feeny.ai/job/sr-manager-quality-assurance-for-quality-control-genetix-biotherapeutics-j6a4xrp93mf0'
type: 'job'
last_seen: '2026-09-07'
---

# Sr. Manager, Quality Assurance for Quality Control at Genetix Biotherapeutics

- **Company:** Genetix Biotherapeutics
- **Location:** Somerville, MA
- **Compensation:** $145k–$196k
- **Posted:** 2026-08-03
- **Last confirmed live:** 2026-09-07
- **Apply:** https://job-boards.greenhouse.io/genetixbiotherapeutics/jobs/8104098

## Job 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.

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

The Sr. Manager, Quality Assurance for Quality Control manages contract testing organizations (CTOs) for all activities associated with Quality Control operation of in-process and release testing for raw materials, starting materials, and drug products in support of our commercial operations.

This position requires close partnering with the CTOs as well as the internal cross-functional teams. The role will provide a significant contribution to the process of sample submission for release testing to Certificate of Analysis (COA) approval. Responsibilities include but are not limited to: ownership and management of quality systems (deviations, change controls, laboratory investigations, and corrective and preventative actions (CAPAs), facilitating meetings both internally and externally with CTO partners including joint management forums and risk assessments to support CTO facing change management and regulatory filings.  Additionally, this person will be responsible for managing the stability program for all three commercial products, including data management, regulatory support.

Job Duties and Responsibilities:

- Manage Quality Control related communications within CTOs and contract manufacturing organizations (CMOs)
- Lead the Stability program focusing on our annual commitment and regulatory filings
- Build on relationships within our CTOs and CMOs ensuring issues impacting Quality Control testing are tracked and resolved in a timely manner
- Own and/or support current good manufacturing practice (cGMP) routine testing by owning quality systems required for deviations, laboratory investigations, and CAPAs
- Lead and/or collaborate with the internal cross-functional team and/or CxOs to review and perform documentation of deviations, laboratory investigations, and CAPAs
- Participate and provide updates on Quality Control lot status at various internal forums
- Lead, support, and mentor other members of the team with any activities related to the responsibilities of this role
- Support process improvement initiatives across the quality department
- Ensure all documentation complies with cGMP regulations and industry guidelines

Essential/Required Qualifications:

- BS or MS in a scientific discipline with 5–10+ years of experience in a QC cGMP clinical and/or commercial environment
- Experience managing CTOs and CMOs, with strong interpersonal and partner-management skills
- Stability program management experience, including familiarity with ICH guidelines
- Direct people-management experience, including management of teams or individual contributors
- Excellent organizational skills and the ability to succeed in a fast-paced environment
- Experience with quality systems supporting deviations, laboratory investigations, and CAPAs
- Strong working knowledge of cGMP, ICH, FDA, and EMA regulations

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 $145,000—$196,000 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.

## About Genetix Biotherapeutics

## Company Overview
- **One-liner**: Genetix Biotherapeutics (formerly bluebird bio) is a commercial-stage biotechnology company dedicated to developing and delivering one-time, curative genetic therapies for patients with severe rare genetic diseases.
- **Entity Type**: Private (taken private in June 2025 after a sale to new ownership)
- **Headquarters**: Somerville, Massachusetts, USA (with a presence in the Netherlands)
- **Founded**: 1992 (founded as Genetix Pharmaceuticals; rebranded to bluebird bio in 2010; rebranded back to Genetix Biotherapeutics in September 2025)
- **Founders**: Not publicly disclosed; the company was originally founded as Genetix Pharmaceuticals in 1992.

## Core Business
- **Primary Industries**: Biotechnology, Gene Therapy, Rare Disease Therapeutics
- **Target Customers**: B2B (healthcare providers, qualified treatment centers, payers/insurers) and B2C (patients with sickle cell disease, β-thalassemia, and cerebral adrenoleukodystrophy)
- **Mission**: "To transform lives through curative therapies for patients with rare, genetic diseases."

## Products & Services
- **LYFGENIA™ (lovotibeglogene autotemcel / lovo-cel)**: An FDA-approved, one-time gene therapy for patients 12 years and older with sickle cell disease. It works by adding functional copies of a modified β-globin gene into the patient's own blood stem cells.
- **ZYNTEGLO™ (betibeglogene autotemcel)**: An FDA-approved, one-time gene therapy for patients with β-thalassemia who require regular blood transfusions. It adds functional copies of a modified β-globin gene into the patient's own blood stem cells.
- **SKYSONA™ (elivaldogene autotemcel)**: An FDA-approved, one-time gene therapy for boys with cerebral adrenoleukodystrophy (CALD), a rare, progressive genetic brain disease. It adds a functional copy of the ABCD1 gene into the patient's own blood stem cells.
- **Patient Support Program**: Personalized assistance for patients and families navigating the treatment journey, including insurance questions, treatment center coordination, and one-on-one support.

## Market Standing
- **Valuation/Market Cap**: Not publicly disclosed (privately held after take-private transaction in June 2025)
- **Key Metrics**:
  - **Annual Revenue**: Not publicly disclosed (but the company reported strong revenue growth in 2025 and achieved its **first ever profitable quarter** in that year)
  - **Total Funding**: Not publicly disclosed (new investors provided "significant capital" to support operational objectives following the take-private transaction)
- **Notable Investors/Partners**: New ownership group (undisclosed); manufacturing partners include **Minaris**, **Lonza**, and **MilliporeSigma** (the U.S. and Canada business of Merck KGaA, Darmstadt, Germany)
- **Growth Signals**:
  - **2025 commercial performance**: >100 patients treated in the U.S.; >150 patients completed their first cell collection cycle; 70 active Qualified Treatment Centers (QTCs) — the largest network for hemoglobinopathy gene therapies nationwide
  - **2026 outlook**: Doubling manufacturing capacity by mid-2026; targeting first full year of profitability; expanding LYFGENIA label to pediatric patients <12 years of age; advancing cryopreserved apheresis to improve the treatment experience

## Competitive Advantages
- **First-mover & market leader**: The only company with FDA approval for three gene therapies, and the market leader in the U.S. for hemoglobinopathy gene therapies
- **Proven commercial model**: >100 patients treated in a single year demonstrates real-world commercial execution and manufacturing scale
- **Decades of scientific innovation**: Over 30 years of R&D in genetic therapy, with extensive clinical data from hundreds of treated patients (including 15-year long-term follow-up studies)
- **Strong access**: LYFGENIA and ZYNTEGLO have meaningful access for >90% of eligible patients with commercial or Medicaid coverage
- **One-time curative approach**: Therapies are designed to treat the underlying cause of disease, offering durable, potentially life-long benefits from a single administration

## Strategic Focus
- **Commercial execution & patient access**: Expanding the Qualified Treatment Center network and making the treatment journey simpler for patients and providers
- **Manufacturing scale-up**: Doubling manufacturing capacity in 2026 through partnerships with CDMOs to meet growing patient demand
- **Process optimization**: Implementing cryopreserved apheresis to improve the patient and provider experience
- **Label expansion**: Advancing the HGB-210 Phase 3 study to bring LYFGENIA to pediatric sickle cell patients under 12 years of age
- **Full-year profitability**: Targeting the company's first full year of profitability in 2026

## Why Work Here
- **Mission-driven culture**: "United by purpose" — the company is laser-focused on transforming the lives of patients with rare, genetic diseases through curative therapies
- **Strong momentum**: Recently achieved first-ever profitable quarter, with rapid commercial growth and a clear plan for expansion in 2026
- **Remote/hybrid policy**: Roles are listed as both on-site (Somerville, MA) and remote (e.g., Account Manager, Gene Therapy) — flexible arrangements appear available depending on the role
- **Active hiring**: 23 job postings as of the search date, spanning Commercial, Quality Assurance, Technical Operations, Medical, and Regulatory functions
- **Experienced leadership**: Led by CEO David Meek (ex-Mirati Therapeutics, Ipsen) with a seasoned executive team of industry veterans, signaling strong strategic direction
- **Notable perks/culture**: High-impact work at the intersection of cutting-edge science and commercial execution; opportunity to join a company in the middle of a dramatic turnaround and growth phase; patient-centric focus with a dedicated support program

## Sources
1. [genetixbiotx.com - Company website](https://www.genetixbiotx.com/)
2. [job-boards.greenhouse.io - Careers page](http://job-boards.greenhouse.io/genetixbiotherapeutics)
3. [linkedin.com - LinkedIn company page](https://www.linkedin.com/company/genetix-biotherapeutics)
4. [genetixbiotx.com - Press release: Rebrand from bluebird bio](https://www.genetixbiotx.com/press-release-2025-09-18.html)
5. [genetixbiotx.com - Press release: 2025 commercial results & 2026 priorities](https://www.genetixbiotx.com/press-release-2026-03-02.html)

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