New · posted Oct 15
Insmed · Biotechnology
Senior Director, Quality Assurance - Gene Therapy
- San Diego, CA
- Hybrid
- Full-time
- Director
Open until filled
The role
The Senior Director Quality Assurance will lead Gene Therapy QA oversight for product programs from toxicology through Phase 3 and commercialization. You will ensure phase-appropriate GMP compliance across manufacturing development, while providing strategic Quality leadership across internal teams and external partners. The role is critical in shaping quality strategy, managing risk, and supporting regulatory readiness for complex, evolving pipelines. This is a supervisory position with 5-9 individual direct reports and would require you to be onsite at least 3 days a week. 30% domestic and international travel, required.
At Insmed, every moment and every patient counts — and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you’ll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person’s contributions to meaningful progress. That commitment has earned us recognition as Science magazine’s No. 1 Top Employer for five consecutive years, certification as a Great Place to Work® in the U.S., and a place on The Sunday Times Best Places to Work list in the UK.
For patients, for each other, and for the future of science, we’re in. Are you?
Where You’ll Work
This is a hybrid role based out of our San Diego, CA office.
- Hybrid
What you need
You have a minimum of a BS degree in Life Sciences, Chemistry, Engineering, or related discipline; advanced degree (MS, PhD, PharmD) strongly preferred.
You are or have:
At least 15 years of relevant Quality Assurance experience in the biopharmaceutical industry, including at least 10 years supporting development-stage Gene Therapy programs; advanced degree may substitute for years of experience.
Strong leadership skills with experience managing and developing high-performing QA teams in a fast-paced, matrixed environment.
Deep knowledge of phase-appropriate quality systems, regulatory requirements (21 CFR Parts 210/211, 600s, 820, ICH, EU Annexes, ISO 13485/14971), and compliance expectations across clinical development.
Demonstrated success in QA oversight of CDMOs, and testing labs, including audit and vendor management experience.
Proven expertise in root cause analysis, investigations, change control, and Quality risk management.
Direct experience with clinical manufacturing, analytical method development/validation, tech transfer, and design control processes.
Experience supporting regulatory submissions (e.g., IND, IMPD, BLA/MAA) with high-quality documentation and Quality strategy input.
Proficient in Microsoft Office and quality system tools (e.g., Veeva, TrackWise, MasterControl); familiarity with data trending/statistical analysis preferred.
ASQ certifications (CQA, CQE) and prior experience in a global development organization are strongly preferred.
What you'll do
In this role, you will have the opportunity to provide strategic and operational Quality leadership for development programs from toxicology through Phase 3, ensuring compliance with GMPs and internal standards.
You will also:
Serve as the Quality lead for GMP activities supporting clinical trial materials, including DS/DP used in early and late-phase studies.
Lead and develop a team of 5–9 Quality professionals supporting development programs; provide coaching, feedback, and career growth opportunities.
Oversee QA support for development-stage manufacturing, analytical, and, including review and approval of deviations, CAPAs, change controls, and protocols/reports.
Collaborate cross-functionally with CMC team, Regulatory, Clinical Operations, and Program Management to drive proactive Quality input into development programs.
Provide Quality oversight of contract development and manufacturing organizations (CDMOs), and other GxP vendors used for clinical trial materials and services. Establish QA-QA relationships and checkpoints for critical CDMOs and service providers.
Lead or support Quality Agreements, risk assessments, audits, and vendor qualification activities to ensure phase-appropriate compliance.
Actively represent QA in technical development activities, including process development, method validation/transfer, formulation work, and scale-up.
Drive phase-appropriate quality system improvements for development-stage programs.
Support regulatory submissions (e.g., IND, IMPD, BLA sections) by reviewing or contributing Quality input and documentation.
·Create, maintain, and enhance Standard Operating Procedures governing Development QA activities.
Support investigations and root cause analysis of product or process issues related to clinical manufacturing.
Pay and benefits
$214,000 – $292,000 a year
Employer provided$214,000.00-292,000.00 Annual
Medical, dental, and vision coverage
Generous paid time off
401(k) with company match
Annual equity awards and ESPP
Company-paid life and disability insurance
Learning Institute and mentorship programs
Where you'll work
San Diego, CAHybridOpen in Maps (opens in a new tab)
More jobs in San Diego, CA
From the posting
About Insmed
Life at Insmed
At Insmed, you’ll find a culture as human as our mission—intentionally designed for the people behind it. You deserve a workplace that reflects the same care you bring to your work each day, with support for how you work, how you grow, and how you show up for patients, your team, and yourself.
Highlights of our U.S. offerings include:
Comprehensive medical, dental, and vision coverage and mental health support, annual wellbeing reimbursement, and access to our Employee Assistance Program (EAP)
Generous paid time off policies, fertility and family-forming benefits, caregiver support, and flexible work schedules with purposeful in-person collaboration
401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP), and company-paid life and disability insurance
Company Learning Institute providing access to LinkedIn Learning, skill building workshops, leadership programs, mentorship connections, and networking opportunities
Employee resource groups, service and recognition programs, and meaningful opportunities to connect, volunteer, and give back
Eligibility for specific programs may vary and is subject to the terms and conditions of each plan.
Current Insmed Employees: Please apply via the Jobs Hub in Workday.
Equal opportunity, accessibility and legal noticesInsmed's statements, word for word
Insmed Incorporated is an Equal Opportunity employer. We do not discriminate in hiring on the basis of physical or mental disability, protected veteran status, or any other characteristic protected by federal, state, or local law. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. For more information, please refer to our Equal Employment Opportunity and Non-Discrimination Statement on our Careers site.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.
Insmed is committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, its services, programs, and activities. To request reasonable accommodation to participate in the job application or interview process, please contact us by email at [email protected] and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.
Applications are accepted for 5 calendar days from the date posted or until the position is filled.
Job intelligence
The context around this role
Live data · October 15, 2026
Salary intelligence
How the pay compares
This role's midpoint is 21% above the US median for Quality Assurance roles at this level.
This roleEmployer provided
Director roles in California26 roles publishing pay
Director roles in the US102 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $214,000 | — | $292,000 |
| California (middle half) | $197,500 | $213,500 | $241,000 |
| All US (middle half) | $186,500 | $209,250 | $231,375 |
This role: Insmed'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 Insmed's own promotion track.
Career resources on Quality Assurance
Skills DNA
What this role leans on
How many of the posting's 29 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- GMP and compliance7
- Collaboration and leadership7
- Quality systems and risk6
- Documentation and SOPs5
- Lab testing and methods4
- Investigations and CAPA3
- Validation and qualification3
- Regulatory submissions2
- 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
- ICHICH quality guidelines(official source, opens in a new tab)Q1 stability, Q2(R2) analytical validation, Q7, Q9 risk management, Q10 quality systems
- ISOISO 13485(official source, opens in a new tab)Quality management systems for medical devices
- ISOISO 14971(official source, opens in a new tab)Risk management for medical devices
- FDAFDA IND(official source, opens in a new tab)Investigational New Drug applications
- FDAFDA BLA(official source, opens in a new tab)Biologics License Applications
Company hiring pulse
Insmed on Regulatory Jobs
- 13
- Open roles
- 13
- Distinct roles
- 3
- Locations
By discipline
- Quality8 62%
- Regulatory4 31%
- Compliance & Safety1 8%
By level
- Director7 54%
- Associate & Specialist3 23%
- Manager2 15%
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Senior Director, Quality Assurance - Gene Therapy at Insmed
Open until filled. $214K–$292K a year, employer provided.