Senior Director, Quality Assurance - Gene Therapy
Insmed Incorporated
August 20, 2026
Remote friendly (San Diego, CA)
United States
Operations
About The Role
Senior Director Quality Assurance for Gene Therapy QA oversight from toxicology through Phase 3 and commercialization. Ensure phase-appropriate GMP compliance across manufacturing development; provide strategic Quality leadership. Supervisory role with 5–9 direct reports; onsite at least 3 days/week. 30% domestic/international travel required.
Responsibilities
- Serve as Quality lead for GMP activities supporting clinical trial materials (DS/DP).
- Lead/develop a team of 5–9 QA professionals (coaching, feedback, career growth).
- Oversee QA support for development-stage manufacturing and analytical activities; review/approve deviations, CAPAs, change controls, and protocols/reports.
- Collaborate with CMC, Regulatory, Clinical Operations, and Program Management.
- Provide QA oversight of CDMOs and other GxP vendors; establish QA–QA relationships/checkpoints.
- Lead/support Quality Agreements, risk assessments, audits, and vendor qualification.
- Represent QA in technical development (process development, method validation/transfer, formulation, scale-up).
- Drive phase-appropriate quality system improvements.
- Support regulatory submissions (e.g., IND, IMPD, BLA sections) with Quality input/documentation.
- Create/maintain/enhance SOPs for Development QA.
- Support investigations and root cause analysis for clinical manufacturing issues.
Qualifications
- BS in Life Sciences/Chemistry/Engineering or related (MS/PhD/PharmD strongly preferred).
- 15+ years biopharma QA, including 10+ years supporting development-stage gene therapy (advanced degree may substitute).
- Deep knowledge of phase-appropriate quality systems and regulations (21 CFR 210/211, 600s, 820, ICH, EU Annexes, ISO 13485/14971).
- Demonstrated QA oversight of CDMOs/testing labs; audit/vendor management.
- Expertise in RCA, investigations, change control, Quality risk management.
- Experience with clinical manufacturing, analytical method development/validation, tech transfer, design control.
- Experience supporting IND/IMPD/BLA/MAA submissions.
- Proficient in MS Office; quality tools (e.g., Veeva, TrackWise, MasterControl); data trending/stat analysis preferred.
- ASQ CQA/CQE and global development organization experience strongly preferred.
Benefits (U.S. offerings)
Medical/dental/vision, mental health support, EAP; wellbeing reimbursement; paid time off; fertility/family-forming and caregiver support; flexible schedule.
401(k) match, annual equity awards, ESPP, company-paid life/disability insurance; learning/leadership programs and mentorship; ERGs and recognition/service.
Application Instructions
- Current Insmed employees: apply via Jobs Hub in Workday.
- Applications accepted for 5 calendar days from the posted date or until filled.
Senior Director Quality Assurance for Gene Therapy QA oversight from toxicology through Phase 3 and commercialization. Ensure phase-appropriate GMP compliance across manufacturing development; provide strategic Quality leadership. Supervisory role with 5–9 direct reports; onsite at least 3 days/week. 30% domestic/international travel required.
Responsibilities
- Serve as Quality lead for GMP activities supporting clinical trial materials (DS/DP).
- Lead/develop a team of 5–9 QA professionals (coaching, feedback, career growth).
- Oversee QA support for development-stage manufacturing and analytical activities; review/approve deviations, CAPAs, change controls, and protocols/reports.
- Collaborate with CMC, Regulatory, Clinical Operations, and Program Management.
- Provide QA oversight of CDMOs and other GxP vendors; establish QA–QA relationships/checkpoints.
- Lead/support Quality Agreements, risk assessments, audits, and vendor qualification.
- Represent QA in technical development (process development, method validation/transfer, formulation, scale-up).
- Drive phase-appropriate quality system improvements.
- Support regulatory submissions (e.g., IND, IMPD, BLA sections) with Quality input/documentation.
- Create/maintain/enhance SOPs for Development QA.
- Support investigations and root cause analysis for clinical manufacturing issues.
Qualifications
- BS in Life Sciences/Chemistry/Engineering or related (MS/PhD/PharmD strongly preferred).
- 15+ years biopharma QA, including 10+ years supporting development-stage gene therapy (advanced degree may substitute).
- Deep knowledge of phase-appropriate quality systems and regulations (21 CFR 210/211, 600s, 820, ICH, EU Annexes, ISO 13485/14971).
- Demonstrated QA oversight of CDMOs/testing labs; audit/vendor management.
- Expertise in RCA, investigations, change control, Quality risk management.
- Experience with clinical manufacturing, analytical method development/validation, tech transfer, design control.
- Experience supporting IND/IMPD/BLA/MAA submissions.
- Proficient in MS Office; quality tools (e.g., Veeva, TrackWise, MasterControl); data trending/stat analysis preferred.
- ASQ CQA/CQE and global development organization experience strongly preferred.
Benefits (U.S. offerings)
Medical/dental/vision, mental health support, EAP; wellbeing reimbursement; paid time off; fertility/family-forming and caregiver support; flexible schedule.
401(k) match, annual equity awards, ESPP, company-paid life/disability insurance; learning/leadership programs and mentorship; ERGs and recognition/service.
Application Instructions
- Current Insmed employees: apply via Jobs Hub in Workday.
- Applications accepted for 5 calendar days from the posted date or until filled.