---
title: 'Associate Manager, Quality Assurance Operations at Genetix Biotherapeutics'
canonical: 'https://feeny.ai/job/associate-manager-quality-assurance-operations-genetix-biotherapeutics-8m008cez8h16'
type: 'job'
last_seen: '2026-09-07'
---

# Associate Manager, Quality Assurance Operations at Genetix Biotherapeutics

- **Company:** Genetix Biotherapeutics
- **Location:** Somerville, MA
- **Compensation:** $115k–$125k
- **Posted:** 2026-08-14
- **Last confirmed live:** 2026-09-07
- **Apply:** https://job-boards.greenhouse.io/genetixbiotherapeutics/jobs/8129898

## 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.

Position Description:

The Associate Manager, Quality Assurance Operations will provide quality oversight of external manufacturing partners to ensure compliance with cGMP requirements, regulatory commitments, and Genetix quality standards. This role will serve as a key quality liaison across internal teams (Manufacturing, MS&T, Quality Control, and Patient Supply) and CMOs, supporting risk management, deviation and change control activities, quality system review, governance forums, and performance monitoring to drive consistent, compliant, and effective operations.

Job Duties and Responsibilities:

- Provide on-call QA support for manufacturing operations, ensuring proactive identification, escalation, and mitigation of quality events and risks impacting ongoing manufacturing and product disposition
- Maintain a consistent and effective external oversight model, including leading QA-to-QA forums and guiding quality discussions in joint governance meetings with CMOs.
- Support regular internal Deviation/Lab Investigation Management meetings, ensuring compliance, quality, and timeliness.
- Review and Approve internal and external CMO Deviations and Change Controls
- Serve as QA point-of-contact for Product Complaints, ensuring appropriate investigation, documentation, and closure.
- Perform Quality Impact Assessments for Change Controls, ensuring appropriate risk evaluation and mitigation.
- Represent Quality Assurance Operations in Manufacturing Tier meetings, ensuring alignment on quality risks, priorities, and escalation pathways.
- Represent Quality Assurance Operations in Change Control Review Board (CCRB) meetings.
- Serve as QA reviewer and approver for: process validation protocols and reports, technical reports and supporting documentation, and internal and external validation deliverables
- Monitor CMO quality performance metrics, identify trends, and drive continuous improvement initiatives.
- Own and manage CMO Quality Agreements, including authoring, reviewing, negotiating, and maintaining compliance with current regulatory expectations.
- Author and review Annual Product Quality Reviews (APQRs) to ensure comprehensive evaluation of product and process performance.
- Identify trends, risks, and opportunities for improvement across the product lifecycle.

Essential/Required Qualifications

Education & Experience

- Bachelor’s degree in Life Sciences, Engineering, or related discipline (advanced degree preferred)
- 4-6 years of experience in Quality Assurance within GMP-regulated biopharmaceutical or cell/gene therapy manufacturing
- Strong experience supporting CMO oversight and external manufacturing environments

Technical Skills

- Deep knowledge of cGMP regulations (FDA, ICH guidelines)
- Deviation, CAPA, and investigation processes
- Change Control systems and validation lifecycle
- Knowledge of lentiviral vector process preferred
- Knowledge of process validation preferred
- Strong understanding of cell/gene therapy manufacturing or biologics

Core Competencies

- Demonstrated ability to lead cross-functional quality governance forums
- Strong risk-based decision-making and escalation capabilities
- Excellent communication, stakeholder management, and influential skills in internal and external settings
- Ability to operate effectively in a fast-paced, matrixed CMO environment
- High attention to detail with an inspection-ready mindset

## Key Success Factors

- Proactive risk identification and escalation during manufacturing operations
- Timely closure and high-quality management of deviations and investigations
- Strong, compliant oversight of CMO operations and quality systems
- Effective cross-functional collaboration and governance leadership
- Continuous improvement of quality systems and performance metrics

Additional Information

- Hybrid schedule based at the company's Somerville, Massachusetts headquarters, with on-site presence expected (three) days per week
- On-call QA support for manufacturing operations
- Prolonged periods of computer-based work.
- Occasional travel
- This position has no direct reports

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 $115,000—$125,000 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)

## Other roles at Genetix Biotherapeutics

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- [Sr. Director, Regulatory Strategy](https://feeny.ai/job/sr-director-regulatory-strategy-genetix-biotherapeutics-somerville-fpj4qjceza7s) — Somerville, MA
- [Manager, End User Services & Lab Support](https://feeny.ai/job/manager-end-user-services-lab-support-genetix-biotherapeutics-somerville-q2ah951d4k1c) — Somerville, MA
- [Director, Regulatory Advertising and Promotion](https://feeny.ai/job/director-regulatory-advertising-and-promotion-genetix-biotherapeutics-somerville-4ykm3383hgsq) — Somerville, MA
- [Regional Medical Director, Gene Therapy](https://feeny.ai/job/regional-medical-director-gene-therapy-genetix-biotherapeutics-remote-wz9vc7s3xy0n)
- [Paralegal and Legal & Compliance Operations Manager](https://feeny.ai/job/paralegal-and-legal-compliance-operations-manager-genetix-biotherapeutics-m768zfn33tct) — Somerville, MA
- [Sr. Manager, Quality Assurance for Quality Control](https://feeny.ai/job/sr-manager-quality-assurance-for-quality-control-genetix-biotherapeutics-j6a4xrp93mf0) — Somerville, MA
- [Director, Value Communications](https://feeny.ai/job/director-value-communications-genetix-biotherapeutics-somerville-yxp6wwwsrt3f) — Somerville, MA
- [Account Manager, Gene Therapy - Pacific Northwest](https://feeny.ai/job/account-manager-gene-therapy-pacific-northwest-genetix-biotherapeutics-seattle-cdgars1xqtra) — Seattle, WA
- [Director of Scientific Communications & Evidence Generation](https://feeny.ai/job/director-of-scientific-communications-evidence-generation-genetix-ddek20fjzkgt) — Somerville, MA