Senior Analyst, Quality Assurance (Analytical)
Insmed Incorporated
August 11, 2026
On-site
San Diego, CA
Operations
About the Role
Senior Analyst (Reporting to Associate Director, Quality – Analytical)
Responsibilities
- Provide QA oversight of internal/external QC activities supporting Gene Therapy programs to ensure compliance with cGMP, global health authority guidelines, regulatory filings, and company procedures.
- Act as primary QA point of contact for assigned products, stability programs, and/or laboratory functions.
- Independently manage routine quality oversight and laboratory record approvals; escalate complex/high-risk/strategic matters to QA leadership.
- Review/approve release and stability analytical testing documentation, raw material qualifications, method validation protocols/reports, and equipment qualification.
- Review/approve SOPs, deviations, investigations, CAPAs, change controls, and supplier notifications.
- Provide QA oversight of OOS/OOT/atypical investigations (root cause + compliant documentation).
- Assess quality impact of lab events; escalate high-risk or potentially regulatory-impacting issues.
- Ensure data integrity compliance (21 CFR Part 11, Annex 11).
- Maintain alignment of analytical methods/documentation with regulatory filings/registrations; track lab metrics/trends and review internal/external method qualification/validation.
- Support audits/inspections and supplier-related quality activities.
Qualifications & Required Skills
- Bachelor’s in Chemistry, Engineering, Life Sciences, or related + 5+ years QA experience in pharma/biotech (preferably supporting QC).
- Must have Gene Therapy and/or biologics experience.
- Strong cGMP and global lab compliance knowledge (FDA/EMA/ICH).
- Experience with deviations, investigations, CAPAs, change controls, method validation oversight.
- Working knowledge of data integrity; risk management tools (e.g., FMEA); QC lab operations and analytical testing.
- Familiarity with HPLC/UPLC, CE-SDS, Cell Based Potency Assay, ddPCR, ELISA, microbiology safety assays.
- Experience with quality/lab systems (e.g., Veeva, LIMS, Chromeleon, BMRAM) and Microsoft Office.
- Strong analytical thinking, judgment, organization, and attention to detail.
Where You’ll Work & Travel
- San Diego office; full-time, in-person. Occasional travel up to ~20%.
Compensation
- Pay range: $100,000.00–$126,500.00 annual.
Application Instructions
- Current Insmed employees: apply via Jobs Hub in Workday. Applications accepted for 5 calendar days from posting date or until filled.
Senior Analyst (Reporting to Associate Director, Quality – Analytical)
Responsibilities
- Provide QA oversight of internal/external QC activities supporting Gene Therapy programs to ensure compliance with cGMP, global health authority guidelines, regulatory filings, and company procedures.
- Act as primary QA point of contact for assigned products, stability programs, and/or laboratory functions.
- Independently manage routine quality oversight and laboratory record approvals; escalate complex/high-risk/strategic matters to QA leadership.
- Review/approve release and stability analytical testing documentation, raw material qualifications, method validation protocols/reports, and equipment qualification.
- Review/approve SOPs, deviations, investigations, CAPAs, change controls, and supplier notifications.
- Provide QA oversight of OOS/OOT/atypical investigations (root cause + compliant documentation).
- Assess quality impact of lab events; escalate high-risk or potentially regulatory-impacting issues.
- Ensure data integrity compliance (21 CFR Part 11, Annex 11).
- Maintain alignment of analytical methods/documentation with regulatory filings/registrations; track lab metrics/trends and review internal/external method qualification/validation.
- Support audits/inspections and supplier-related quality activities.
Qualifications & Required Skills
- Bachelor’s in Chemistry, Engineering, Life Sciences, or related + 5+ years QA experience in pharma/biotech (preferably supporting QC).
- Must have Gene Therapy and/or biologics experience.
- Strong cGMP and global lab compliance knowledge (FDA/EMA/ICH).
- Experience with deviations, investigations, CAPAs, change controls, method validation oversight.
- Working knowledge of data integrity; risk management tools (e.g., FMEA); QC lab operations and analytical testing.
- Familiarity with HPLC/UPLC, CE-SDS, Cell Based Potency Assay, ddPCR, ELISA, microbiology safety assays.
- Experience with quality/lab systems (e.g., Veeva, LIMS, Chromeleon, BMRAM) and Microsoft Office.
- Strong analytical thinking, judgment, organization, and attention to detail.
Where You’ll Work & Travel
- San Diego office; full-time, in-person. Occasional travel up to ~20%.
Compensation
- Pay range: $100,000.00–$126,500.00 annual.
Application Instructions
- Current Insmed employees: apply via Jobs Hub in Workday. Applications accepted for 5 calendar days from posting date or until filled.