New · posted Oct 17
Insmed · Pharmaceuticals
QMS Specialist, Quality Assurance
- San Diego, CA
- On-site
- Full-time
- Associate & Specialist
Open until filled
The role
Reporting to the Associate Director, Quality Assurance GMP, the QMS Specialist, Quality Assurance, will play a key role in managing QA and Regulatory Compliance activities for Insmed Gene Therapy. This role directly influences Insmed GMP compliance through QA oversight, monitoring and review of Quality System activities. In coordination with the Associate Director, Quality Assurance GMP, primary areas of responsibility include Documentation Review and Monitoring, Review, and Approval of Quality Docs and QMS tasks including Change Controls, CAPAs, Deviations, Document Change Controls, Effectiveness Checks, Periodic Reviews, Quality System Metric Reviews, and related SOPs for these systems. Additional responsibilities include Training Administration for site LMS curricula, such as creation of new user training accounts, monitoring and closure of ServiceNow tickets, updates to training curricula, assignment of training curricula to users, and tracking of trainings coming due.
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 role is based out of our San Diego office and requires full-time, in-person presence to support hands-on collaboration, access specialized equipment, and/or operational needs.
#
What you need
What you'll do
In this role, you’ll have the opportunity to oversee the completion of Quality Management System (QMS) records for Insmed Gene Therapy including Document Change Controls, Change Controls, CAPAs, Deviations, Effectiveness Checks, and Periodic Reviews. You'll also:
- Monitor the Learning Management System (LMS) and perform site training administrator tasks, such as creation of new user training accounts, monitoring and closure of ServiceNow tickets, update to training curricula, assignment of training curricula to users, and tracking of trainings coming due.
- Provide input on QMS processes including process design, monitoring for compliance, continuous improvement activities, metrics, and day-to-day operations.
- Support facilitation of Change Control Committee materials and review and approval of changes presented to committee. Facilitate feedback from Change Control Committee Members Perform QA review of Change Controls, CAPA, Deviations, and Effectiveness Checks. Ensure completeness, accuracy, and compliance to all applicable cGMP regulations.
- Handle compilation of quality metrics for trending and follow up for the closure of process improvements. Present and communicate trending reports in respective Quality forums.
- Support training of Insmed Gene Therapy employees in QMS processes.
- Upload and route Quality Records for approval in Veeva Quality Documents electronic documentation system. Perform QA Document Control review and approval of document updates.
- Ensure QMS records comply with process requirements, including use of appropriate document templates, where applicable.
- Review and update SOPs, policies, and standards regularly to ensure compliance with GxP standards, FDA/EMA/ICH and other applicable competent authority regulations and requirements.
- Monitor documents for Periodic Review process and work with document owners to ensure timely document review and update, as applicable.
- Assist in inspection readiness activities and plays a key role during inspections/audits for QMS activities. Provide support during internal review, Audits, FDA Audits, and Third-party consultant Audits.
You will have a minimum of a BS degree in Chemistry, Engineering, Life Science or related discipline AND/OR 6 years of relevant Quality Assurance experience. You are or you have:
- Direct experience with Change Control, Document Control, Deviations, CAPAs, and Effectiveness Checks in pharmaceutical or medical device products.
- Understanding of cGMPs for pharmaceutical products.
- Familiarity of pharmaceutical product manufacturing processes, medical devices, and analytical laboratory practices.
- Experience working with an electronic document management system.
- Experience at reviewing procedural documents, change controls, manufacturing investigations, and lab investigations.
- Demonstrate ability to manage projects and variable workloads.
- Highly organized with a strong attention to detail, clarity, accuracy and conciseness.
- Highly proficient in Microsoft Office (Word, Excel, PowerPoint and Outlook).
- Proficient in analyzing data trends in Excel or Minitab.
Pay and benefits
$81,000 – $103,000 a year
Employer provided$81,000.00-103,000.00 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
Fertility and family-forming benefits
Where you'll work
San Diego, CAOn-siteOpen 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 17, 2026
Salary intelligence
How the pay compares
This role's midpoint is 15% above the US median for Quality Assurance roles at this level.
This roleEmployer provided
Associate & Specialist roles in California27 roles publishing pay
Associate & Specialist roles in the US161 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $81,000 | — | $103,000 |
| California (middle half) | $78,250 | $88,500 | $102,250 |
| All US (middle half) | $59,000 | $80,000 | $94,000 |
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 17, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Assurance
The general path across 852 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 26 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Documentation and SOPs10
- Quality systems and risk10
- GMP and compliance5
- Investigations and CAPA5
- Collaboration and leadership5
- Data and digital systems3
- Lab testing and methods1
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.
Company hiring pulse
Insmed on Regulatory Jobs
- 15
- Open roles
- 15
- Distinct roles
- 3
- Locations
By discipline
- Quality9 60%
- Regulatory5 33%
- Compliance & Safety1 7%
By level
- Director8 53%
- Associate & Specialist4 27%
- Manager2 13%
More roles at Insmed
- View role
Summer Intern – CMC Quality Assurance, Clinical Programs
Remote, USAssociate & SpecialistPharmaceuticals$42K–$73K
- View role
Specialist, Quality CMC Operations
Bridgewater, NJ · HybridAssociate & SpecialistPharmaceuticals$81K–$104K
- View role
Manager, Product Quality Complaint Data Analytics
Bridgewater, NJ · HybridManagerPharmaceuticals$124K–$161K
- View role
Senior Director, Quality Assurance - Gene Therapy
San Diego, CA · HybridDirectorBiotechnology$214K–$292K
Similar Quality Assurance roles elsewhere
- View role
QA Specialist (Batch Record Reviewer)
AbbVieWaltham, MAAssociate & SpecialistPharmaceuticals$59K–$104K
- View role
Quality Complaint Specialist
SanofiSwiftwater, PAAssociate & SpecialistPharmaceuticals$69K–$100K
- View role
Change Control and Quality Systems Specialist
Thermo Fisher ScientificGreenville, NCAssociate & SpecialistPharmaceuticalsSalary not listed
- View role
Quality Assurance At-the-Source Specialist, Cell Therapy
AstraZenecaRockville, MDAssociate & SpecialistPharmaceuticals$101K–$151K
QMS Specialist, Quality Assurance at Insmed
Open until filled. $81K–$103K a year, employer provided.