New · posted Oct 15
Genetix Biotherapeutics · Biotechnology
Senior Director, Quality Operations
- Somerville, MA
- Hybrid
- Full-time
- Director
Open until filled
The role
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.
What you need
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 Qualificationsnice to have
- 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
What you'll do
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.
Pay and benefits
$250,000 – $302,000 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
$250,000—$302,000 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.
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.
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 32% above the US median for Quality Assurance roles at this level.
This roleEmployer provided
Director roles in Massachusetts33 roles publishing pay
Director roles in the US102 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $250,000 | — | $302,000 |
| Massachusetts (middle half) | $186,000 | $204,500 | $231,000 |
| All US (middle half) | $186,500 | $209,250 | $231,375 |
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 42 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- GMP and compliance13
- Collaboration and leadership12
- Quality systems and risk4
- Lab testing and methods3
- Investigations and CAPA2
- Regulatory submissions2
- Documentation and SOPs1
- Validation and qualification1
- Data and digital systems1
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 data integrity guidance(official source, opens in a new tab)Data Integrity and Compliance With Drug CGMP: Questions and Answers
- 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
- FDAFDA BLA(official source, opens in a new tab)Biologics License Applications
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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Senior Director, Quality Operations at Genetix Biotherapeutics
Open until filled. $250K–$302K a year, employer provided.