Manager, Quality Control
Insmed Incorporated
August 20, 2026
On-site
San Diego, CA
Operations
Manager, Quality Control (Quality Control)
What You’ll Do:
- Oversee and perform testing of HPLC and compendial methods.
- Establish/qualify QC test methods; author/revise SOPs; manage quality events.
- Perform and oversee testing of compendial and HPLC, CE-SDS, ICP-MS methods for the product purity group.
- Ensure timely execution of routine QC testing, data review/trending, and preparation of summary reports.
- Perform/oversee quality events (deviations, CAPA, change control, investigation of OOS/OOT/atypical results) in the company QMS.
- Author, review, and approve QC analytical SOPs, protocols, and reports.
- Serve as SME for HPLC, CE-SDS, pH, osmolality, appearance, ICP-MS, and DLS.
- Develop timelines/protocols for assay transfers, qualifications, and validations; support method transfer between lab and CDMOs.
- Manage QC laboratory operations, track critical reagents/logbooks, ensure equipment calibration.
- Use software (Labware LIMS, JMP, Chromeleon, etc.) and support implementation of new software/updates.
- Establish laboratory and participate in hiring and training QC staff.
Qualifications:
- Bachelor’s degree; 7+ years of quality control experience.
- Gene therapy/GMP testing experience; GMP QC release testing experience.
- Method development experience (HPLC, ICP-MS elemental analysis, CE-SDS protein purity, compendial methods).
- Significant FDA-regulated environment experience.
- Excellent organizational/communication skills; experience managing people.
Where You’ll Work:
- San Diego, CA office; full-time, in-person.
Pay Range:
- $124,000.00–161,000.00 annual.
U.S. Offerings Include:
- Medical/dental/vision, mental health support, EAP; annual wellbeing reimbursement.
- Paid time off; fertility/family-forming benefits; caregiver support.
- 401(k) with company match; annual equity awards; ESPP; company-paid life/disability.
Application:
- Current employees: apply via Jobs Hub in Workday.
What You’ll Do:
- Oversee and perform testing of HPLC and compendial methods.
- Establish/qualify QC test methods; author/revise SOPs; manage quality events.
- Perform and oversee testing of compendial and HPLC, CE-SDS, ICP-MS methods for the product purity group.
- Ensure timely execution of routine QC testing, data review/trending, and preparation of summary reports.
- Perform/oversee quality events (deviations, CAPA, change control, investigation of OOS/OOT/atypical results) in the company QMS.
- Author, review, and approve QC analytical SOPs, protocols, and reports.
- Serve as SME for HPLC, CE-SDS, pH, osmolality, appearance, ICP-MS, and DLS.
- Develop timelines/protocols for assay transfers, qualifications, and validations; support method transfer between lab and CDMOs.
- Manage QC laboratory operations, track critical reagents/logbooks, ensure equipment calibration.
- Use software (Labware LIMS, JMP, Chromeleon, etc.) and support implementation of new software/updates.
- Establish laboratory and participate in hiring and training QC staff.
Qualifications:
- Bachelor’s degree; 7+ years of quality control experience.
- Gene therapy/GMP testing experience; GMP QC release testing experience.
- Method development experience (HPLC, ICP-MS elemental analysis, CE-SDS protein purity, compendial methods).
- Significant FDA-regulated environment experience.
- Excellent organizational/communication skills; experience managing people.
Where You’ll Work:
- San Diego, CA office; full-time, in-person.
Pay Range:
- $124,000.00–161,000.00 annual.
U.S. Offerings Include:
- Medical/dental/vision, mental health support, EAP; annual wellbeing reimbursement.
- Paid time off; fertility/family-forming benefits; caregiver support.
- 401(k) with company match; annual equity awards; ESPP; company-paid life/disability.
Application:
- Current employees: apply via Jobs Hub in Workday.