New · posted Oct 15
Insmed · Biotechnology
Senior Analyst, Quality Assurance
- San Diego, CA
- Hybrid
- Full-time
- Senior & Principal
Open until filled
The role
Reporting to the Associate Director, Quality – Analytical, the Senior Analyst is responsible for providing Quality Assurance oversight of internal and external Quality Control activities supporting Gene Therapy programs. This role ensures analytical testing, stability programs, and laboratory operations are conducted in compliance with cGMP regulations, global health authority guidelines, regulatory filings, and company procedures.
You will serve as the primary QA point of contact for assigned products or laboratory functions, independently managing routine quality oversight and laboratory record approvals while escalating complex, high-risk, or strategic matters to QA leadership as appropriate. This position requires a strong quality mindset, technical understanding of analytical testing, and the ability to apply risk-based decision-making to maintain compliant, inspection-ready operations aligned with product lifecycle requirements.
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 office. You’ll have the option to work remotely with in-person collaboration 3 -4 days a week.
What you need
You have a minimum of a Bachelor's degree in in Chemistry, Engineering, Life Sciences, or a related discipline along with 5+ years of experience in Quality Assurance experience within the pharmaceutical or biotechnology industry, preferably supporting Quality Control operations. You are or you have:
- Experience supporting Gene Therapy and/or biologics experience, a must.
- Strong knowledge of cGMP regulations and global laboratory compliance standards (FDA, EMA, ICH).
- Experience with deviations, investigations, CAPAs, change controls, and method validation oversight.
- Working knowledge of data integrity principles and regulatory expectations, including electronic records and laboratory systems compliance.
- Familiarity with risk management tools (e.g., FMEA) and risk-based decision-making.
- Solid understanding of QC laboratory operations and analytical testing.
- Familiarity with analytical techniques such as HPLC/UPLC, CE-SDS, Cell Based Potency Assay, ddPCR, ELISA, Microbiology safety assay and related methodologies.
- Experience with quality and laboratory systems (e.g., Veeva, LIMS, Chromeleon, BMRAM or equivalent).
- Proficiency in Microsoft Office applications (Word, Excel, PowerPoint, Outlook).
- Strong analytical thinking and sound judgment. Highly organized with strong attention to detail, accuracy, and clarity.
Travel Requirements
This role requires occasional travel (approximately up to 20%).
What you'll do
In this role, you’ll have the opportunity to provide QA oversight of internal and external QC laboratory operations to ensure compliance with cGMP regulations and global health authority requirements. You’ll also:
- Serve as the QA point of contact for assigned products, stability programs, and/or laboratory functions.
- Review and approve release and stability analytical testing documentation, raw material qualifications, method validation protocols and reports, and equipment qualification documentation. Review and approve SOPs, deviations, investigations, CAPAs, change controls, and supplier notifications.
- Provide QA oversight of OOS, OOT, and atypical laboratory investigations to ensure scientifically sound root cause analysis and compliant documentation.
- Assess quality impact of laboratory events and escalate high-risk, cross-functional, or potentially regulatory-impacting issues to QA management as appropriate.
- Review and approve equipment qualification, calibration and maintenance program.
- Ensure compliance with data integrity requirements, including 21 CFR Part 11 and Annex 11.
- Ensure analytical methods and documentation remain aligned with regulatory filings and current product registrations.
- Track record status and analyze laboratory metrics and analytical trends to support compliance and continuous improvement. Review and approve internal and external analytical method qualification/validation.
- Participate in cross-functional discussions to provide quality input and risk-based recommendations.
- Support internal and external audits, regulatory inspections, and supplier-related quality activities as needed. Partner with QC to drive continuous improvement initiatives and maintain audit readiness.
Pay and benefits
$100,000 – $127,000 a year
Employer provided$100,000.00-126,500.00 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 development 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.
Important Notice for Job Seekers: Insmed will only communicate with candidates from an @insmed.com email address and will never request payment of any kind during the hiring process. If you'd like guidance on recognizing potential recruitment fraud, please reach out to [email protected].
Job intelligence
The context around this role
Live data · October 15, 2026
Salary intelligence
How the pay compares
This role's midpoint is 8% below the US median for Quality Assurance roles at this level.
This roleEmployer provided
Senior & Principal roles in California84 roles publishing pay
Senior & Principal roles in the US284 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $100,000 | — | $127,000 |
| California (middle half) | $118,625 | $135,000 | $158,625 |
| All US (middle half) | $103,375 | $122,750 | $137,500 |
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 28 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Lab testing and methods16
- GMP and compliance8
- Documentation and SOPs7
- Quality systems and risk5
- Validation and qualification4
- Data and digital systems4
- Collaboration and leadership4
- Investigations and CAPA3
- Regulatory submissions2
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
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- FDAFDA data integrity guidance(official source, opens in a new tab)Data Integrity and Compliance With Drug CGMP: Questions and Answers
- FDAFDA OOS guidance(official source, opens in a new tab)Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production
- ICHICH quality guidelines(official source, opens in a new tab)Q1 stability, Q2(R2) analytical validation, Q7, Q9 risk management, Q10 quality systems
- European CommissionEU GMP (EudraLex Volume 4)(official source, opens in a new tab)The EU's good manufacturing practice rules and annexes
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 Analyst, Quality Assurance at Insmed
Open until filled. $100K–$127K a year, employer provided.