---
title: 'Sr. Director, Quality Operations at Genetix Biotherapeutics'
canonical: 'https://feeny.ai/job/sr-director-quality-operations-genetix-biotherapeutics-somerville-traazwk35kj1'
type: 'job'
last_seen: '2026-10-12'
---

# Sr. Director, Quality Operations at Genetix Biotherapeutics

- **Company:** Genetix Biotherapeutics
- **Location:** Somerville, MA
- **Compensation:** $250k–$302k
- **Posted:** 2026-09-21
- **Last confirmed live:** 2026-10-12
- **Apply:** https://job-boards.greenhouse.io/genetixbiotherapeutics/jobs/8221581

## 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 based in our Somerville, Massachusetts (Assembly Row) office, with an onsite presence required three days per week. Candidates must reside within a commutable distance of the office to be considered.

The Senior Director, Quality Operations is a senior quality leader responsible for providing strategic and operational leadership for commercial Quality Operations, including external manufacturing and testing oversight, lot disposition, quality governance, and patient-specific product controls across clinical and commercial-stage supply. This role is critical in a virtual operating model and ensures that all Contract Development and Manufacturing Organizations (CDMOs), testing laboratories, and other GxP service providers operate in full compliance with global regulatory requirements and company quality standards.

This role partners closely with Manufacturing, Technical Operations, Supply Chain, Regulatory Affairs, Medical, Patient Operations, and Commercial teams to ensure uninterrupted and compliant patient supply, timely quality decisions, and sustained inspection readiness as the organization scales.

## RESPONSIBILITIES

External Manufacturing Quality Oversight

- Provide end-to-end quality oversight of external manufacturers (CDMOs) supporting clinical and commercial cell and gene therapy products.
- Establish and maintain CDMO quality agreements, ensuring clear delineation of responsibilities for commercial operations.
- Oversee performance monitoring, periodic review, and ongoing approval of CDMOs, contract testing laboratories, logistics providers, and other critical GxP service providers.
- Establish risk-based quality scorecards and ensure significant performance or compliance concerns are escalated and remediated.
- Serve as the primary quality point of contact for assigned external partners, fostering strong, collaborative relationships.

Commercial Product Support

- Ensure compliant commercial product release, disposition, and lifecycle management, including deviations CAPAs, change controls, and investigations.
- Oversee lot disposition activities in collaboration with internal stakeholders, ensuring timely and compliant decision-making.
- Provide independent Quality oversight and make or escalate timely decisions regarding product quality, patient impact, lot disposition, and regulatory compliance.
- Ensure robust controls for chain of identity, chain of custody, patient-specific labeling, product traceability, sample management, and temperature-controlled transportation.
- Support the Annual Product Quality Reviews/Product Quality Reviews and product-quality trending for assigned products and external manufacturing sites.
- Support process validation, continued process verification (CPV), comparability assessments, and post-approval changes.

Regulatory & Inspection Readiness

- Lead external quality readiness for FDA inspections, including PAIs and commercial inspections.
- Participate directly in regulatory inspections and audits as a company representative.
- Ensure timely and effective resolution of inspection findings, observations, and commitments.
- Partner with Regulatory Affairs to support regulatory filings, post-approval changes, regulatory commitments, and assessments of potentially reportable quality events.

Audit & Compliance Leadership

- Ensure effective management of CDMO audit observations, deviations, and CAPAs to closure.
- Monitor compliance trends and proactively identify and mitigate quality risks across the external network.

Quality Systems & Governance

- Drive continuous improvement of external quality processes aligned with a virtual operating model.
- Ensure external partners comply with company Quality Management System (QMS), including documentation, training, data integrity, and change management.
- Contribute to enterprise-level quality metrics, governance forums, and management reviews.

Leadership & Cross-Functional Partnership

- Lead, mentor, and develop a high-performing Quality Operations team.
- Act as a strategic quality advisor to senior leadership and cross-functional teams.
- Support company growth through onboarding of new external partners and technologies.
- Establish clear priorities, resource plans, roles, and accountability for the Quality Operations organization.
- Develop organizational capability through coaching, succession planning, technical development, and performance management.
- Serve as an escalation point for significant product-quality, compliance, patient-supply, and external-partner issues.

## QUALIFICATIONS

Required Qualifications

- Bachelor’s degree in Life Sciences, Engineering, or related discipline (advanced degree preferred).
- 12+ years of progressive experience in Quality Operations, External Quality, or Manufacturing within
- Prior people leadership experience at the Director or Senior Director level.
- Demonstrated experience supporting commercial-stage products and post-approval lifecycle management.
- Deep knowledge of GMP regulations (FDA, EMA, ICH) applicable to biologics and advanced therapies.
- Proven success working in a virtual or highly outsourced operating model.
- Experience supporting global regulatory inspections.

## Preferred Qualifications

- Experience with autologous and/or allogeneic cell therapy manufacturing models.
- Experience supporting BLA/MAA submissions, post-approval changes, and commercial expansions.

## Key Competencies

- Strategic thinking with strong operational execution
- Strong decision-making and risk-based quality mindset
- Ability to influence and lead without direct authority
- Excellent communication and executive presence
- Comfortable operating in fast-paced, evolving environments

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 $250,000—$302,000 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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