Insmed

Senior Director, Quality Assurance - Gene Therapy

Research Development Lab - San Diego · Director

Sponsorship not specified$214k-$292kDetected 98 days ago

StatisticsVendor ManagementHRGMPCRISPRMedical DevicesLeadershipMentoringMicrosoft OfficeGxP

About the role

The role is critical in shaping quality strategy, managing risk, and supporting regulatory readiness for complex, evolving pipelines.
This is a supervisory position with 5-9 individual direct reports and would require you to be onsite at least 3 days a week.
In this role, you will have the opportunity to p rovide strategic and operational Quality leadership for development programs from toxicology through Phase 3, ensuring compliance with GMPs and internal standards.

Serve as the Quality lead for GMP activities supporting clinical trial materials, including DS/DP used in early and late-phase studies.
Lead and develop a team of 5-9 Quality professionals supporting development programs
Oversee QA support for development-stage manufacturing, analytical, and, including review and approval of deviations, CAPAs, change controls, and protocols/reports.
Collaborate cross- functionally with CMC team, Regulatory, Clinical Operations, and Program Management to drive proactive Quality input into development programs.
Lead or support Quality Agreements, risk assessments, audits, and vendor qualification activities to ensure phase-appropriate compliance.
Drive phase-appropriate quality system improvements for development-stage programs.
Support regulatory submissions (e.g., IND, IMPD, BLA sections) by reviewing or contributing Quality input and documentation.
Create, maintain, and enhance Standard Operating Procedures governing Development QA activities.
Support investigations and root cause analysis of product or process issues related to clinical manufacturing.
At Insmed, you'll find a culture as human as our mission-intentionally designed for the people behind it.

At least 15 years of relevant Quality Assurance experience in the biopharmaceutical industry, including at least 10 years supporting development-stage Gene Therapy programs
advanced degree may substitute for years of experience.
Deep knowledge of phase-appropriate quality systems, regulatory requirements (21 CFR Parts 210/211, 600s, 820, ICH, EU Annexes, ISO 13485/14971), and compliance expectations across clinical development.
Demonstrated success in QA oversight of CDMOs, and testing labs, including audit and vendor management experience.
Proven expertise in root cause analysis, investigations, change control, and Quality risk management.
Direct experience with clinical manufacturing, analytical method development/validation, tech transfer, and design control processes.
Experience supporting regulatory submissions (e.g., IND, IMPD, BLA/MAA) with high-quality documentation and Quality strategy input.
Proficient in Microsoft Office and quality system tools (e.g., Veeva, TrackWise, MasterControl )

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
$214,000.00-292,000.00 Annual
Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established.

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
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.

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.

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.