Insmed
Director, Quality Assurance Systems
Research Development Lab - San Diego · Director
Sponsorship not specified$177k-$242kDetected 160 days ago
AuditingHRGMPFDA RegulatoryCRISPRResearchLeadershipCommunicationCollaborationMentoringOrganizational SkillsGxP
Stay score
odds of building a lasting career here
59Sponsors, lottery-bound
Cap-exempt (no lottery)0
Sponsors this role80
Entry-level history0
PERM / green-card track0
Lottery odds (Level IV)94
Fits your clock70
Sponsors, but it's cap-subject — you still face the weighted lottery (~61% per draw at Level IV). Good if you win; have a cap-exempt backup on your list.
Lottery odds assume a STEM candidate.
Personalize to your clock →H-1B wage level
the lottery is wage-weighted — each level is one more entry
Level I$73,4241 entry
Level II$95,9922 entries
Level III$118,5393 entries
Level IV$141,1074 entries
This range already reaches Level IV — the maximum four lottery entries.
DOL prevailing wage, 2026-27 wage year · Software Quality Assurance Analysts and Testers (15-1253) · San Diego-Chula Vista-Carlsbad, CA. Wage level is derived by USCIS from the offered wage, occupation and worksite; the occupation shown is inferred from the job title.
Employer immigration record
from this employer's Department of Labor filings
Files H-1B transfers
2 transfer filings in the last year, covering 2 workers. Median labor-condition decision: 8 days. An employer that already files transfers is one that can take over an existing H-1B.
Sourced from Department of Labor LCA, PERM and prevailing-wage disclosure data. Employer matching is by name, so figures may be split across an employer's legal entities. Absence of a filing means none appears in our copy of the data, not that none exists.
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About the role
- Responsible for the local processes related to QMS, IT Change Control, Computerized System Validation, Data Integrity for electronic systems, and monitoring/auditing of audit trails.
- Provide leadership and management within the department through a structural process of objective setting, performance appraisal and individual development, including delivery of multiple projects of various complexities
Responsibilities
- In this role, you will lead the implementation, validation, and lifecycle management of GxP digital systems within an FDA-regulated (or equivalent global regulatory) environment supporting Gene Therapy programs.
- Provide guidance to team members on software development life cycle, computer validation, and drive a risk-based approach methodology with all stakeholders.
- Provide oversight to the implementation and validation of GxP software applications/modules and associated interfaces according to business needs and internal procedures (support system upgrades, change control, retrospective validation, software add-on installations where capable).
- Writes SOPs and other quality system documentation, assists other departments with the generation, review and approval and maintenance of such documents.
- Provide support during regulatory inspections and internal audits
- 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.
Requirements
- You have a Bachelor's degree and a minimum of 10 years of relevant Quality Assurance experience.
- An advanced degree (MS) and a minimum of 5 years relevant experience will also be considered
- Additionally, you have:
- Experience as QA reviewer of several GMP records and processes: CSV Validation Protocols, Deviations, CAPA, SOPs, etc..
- Must have excellent communication skills (verbal and written).
- Working knowledge of all GxP regulations and reporting requirements, quality systems, Computer System Validation, and quality management tools.
- Experience with Veeva systems, LIMS (e.g., Labware), Chromatography Data Systems (e.g., Waters Empower, Nugenesis, Thermo Chromeleon), and/or Electronic Lab Notebooks (ELN) is required.
- Role-related knowledge: Working knowledge of all GxP regulations and reporting requirements, quality systems, Computer System Validation, and quality management tools.
Nice to have
- Preferred experience in Data Integrity, 21 CFR Part 11, Annex 11, GAMP 5, SDLC (Agile or Waterfall), CSA
Compensation
- $177,000.00-242,000.00 Annual
- Comprehensive medical, dental, and vision coverage and mental health support, annual wellbeing reimbursement, and access to our Employee Assistance Program (EAP)
- 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
- Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established.
Benefits
- 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
Company info
- 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.
Equal opportunity
- Insmed Incorporated is an Equal Opportunity employer.
- 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 TotalRewards@insmed.com 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.
This listing is sourced directly from Insmed's careers page and normalized into a canonical job model.