New · posted Oct 15
Genetix Biotherapeutics · Biotechnology
Manager, Quality Assurance Operations
- Somerville, MA
- Hybrid
- Full-time
- Manager
Open until filled
The role
The ‘Manager, Quality Assurance Operations’ role is responsible for providing end-to-end quality oversight of Contract Manufacturing Organizations (CMOs) to ensure compliance with cGMP regulations, regulatory commitments, and Genetix quality standards. This role serves as a key quality partner to Manufacturing, MS&T, Quality Control, and Patient Supply. The role is expected to serve as a CMO Lead point-of-contact and primary quality interface with external partners, driving proactive risk management, and Deviation and Change Control lifecycle management. The position ensures effective quality oversight through structured governance forums, review and approval of quality systems, and continuous monitoring of performance metrics.
This is a full-time hybrid position (3 days a week) in our Somerville – Assembly Row, Massachusetts office.
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
What you need
Required Education, Experience, or Qualifications (or equivalent)
Education & Experience
• Bachelor’s degree in Life Sciences, Engineering, or related discipline (advanced degree preferred)
• 7+ 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, EMA, 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
Leadership & 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
What you'll do
• 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.
• Lead 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.
Pay and benefits
$118,000 – $166,000 a year
Employer providedAdditional 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
$118,000—$166,000 USD
Health, life and disability insurance
Employer-matched 401(k)
Lifestyle spending account
Flexible time off and paid holidays
Tuition reimbursement and loan repayment assistance
Paid parental leave
Where you'll work
Somerville, MAHybridOpen in Maps (opens in a new tab)
More jobs in Somerville, MAFrom the posting
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.
Equal opportunity, accessibility and legal noticesGenetix Biotherapeutics's statements, word for word
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.
Job intelligence
The context around this role
Live data · October 15, 2026
Salary intelligence
How the pay compares
This role's midpoint is 7% below the US median for Quality Assurance roles at this level.
This roleEmployer provided
Manager roles in Massachusetts18 roles publishing pay
Manager roles in the US105 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $118,000 | — | $166,000 |
| Massachusetts (middle half) | $116,500 | $133,250 | $153,000 |
| All US (middle half) | $126,000 | $153,000 | $167,500 |
This role: Genetix Biotherapeutics's own published range. Comparisons: the base pay employers published on open Quality Assurance roles at the same level on Regulatory Jobs, October 15, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Assurance
The general path across 845 open Quality Assurance roles on Regulatory Jobs, with the titles they carry most. Not Genetix Biotherapeutics's own promotion track.
Career resources on Quality Assurance
Skills DNA
What this role leans on
How many of the posting's 13 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- GMP and compliance6
- Collaboration and leadership6
- Quality systems and risk5
- Investigations and CAPA4
- Documentation and SOPs2
- Validation and qualification2
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- FDA21 CFR Parts 210 and 211(official source, opens in a new tab)FDA current good manufacturing practice for finished pharmaceuticals
- FDAFDA process validation guidance(official source, opens in a new tab)Process Validation: General Principles and Practices
- ICHICH quality guidelines(official source, opens in a new tab)Q1 stability, Q2(R2) analytical validation, Q7, Q9 risk management, Q10 quality systems
Company hiring pulse
Genetix Biotherapeutics on Regulatory Jobs
- 6
- Open roles
- 6
- Distinct roles
- 1
- Locations
By discipline
- Quality4 67%
- Regulatory2 33%
By level
- Director3 50%
- Manager3 50%
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Manager, Quality Assurance Operations at Genetix Biotherapeutics
Open until filled. $118K–$166K a year, employer provided.