Senior Director, Quality Assurance - Gene Therapy

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. Are you?About the Role:The Senior Director Quality Assurance will lead Gene Therapy QA oversight for product programs from toxicology through Phase 3 and commercialization. You will ensure phase-appropriate GMP compliance across manufacturing development, while providing strategic Quality leadership across internal teams and external partners. 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. 30% domestic and international travel, required.What You'll Do: In this role, you will have the opportunity to provide strategic and operational Quality leadership for development programs from toxicology through Phase 3, ensuring compliance with GMPs and internal standards. You will also: 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; provide coaching, feedback, and career growth opportunities. 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. Provide Quality oversight of contract development and manufacturing organizations (CDMOs), and other GxP vendors used for clinical trial materials and services. Establish QA-QA relationships and checkpoints for critical CDMOs and service providers. Lead or support Quality Agreements, risk assessments, audits, and vendor qualification activities to ensure phase-appropriate compliance. Actively represent QA in technical development activities, including process development, method validation/transfer, formulation work, and scale-up.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.Who You Are:You have a minimum of a BS degree in Life Sciences, Chemistry, Engineering, or related discipline; advanced degree (MS, PhD, PharmD) strongly preferred.You are or have: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.Strong leadership skills with experience managing and developing high-performing QA teams in a fast-paced, matrixed environment.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); familiarity with data trending/statistical analysis preferred.ASQ certifications (CQA, CQE) and prior experience in a global development organization are strongly preferred. Where You’ll Work This is a hybrid role based out of our San Diego, CA office.#LI-SK1#LI-SK - HybridPay Range:$214,000.00-292,000.00 AnnualLife at Insmed 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.Highlights of our U.S. offerings include: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 collaboration401(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 insuranceCompany Learning Institute providing access to LinkedIn Learning, skill building workshops, leadership programs, mentorship connections, and networking opportunitiesEmployee resource groups, service and recognition programs, and meaningful opportunities to connect, volunteer, and give backEligibility for specific programs may vary and is subject to the terms and conditions of each plan. Current Insmed Employees: Please apply via the Jobs Hub in Workday.Insmed Incorporated is an Equal Opportunity employer. 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. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.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 View email address on click.appcast.io 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. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.Applications are accepted for 5 calendar days from the date posted or until the position is filled.For New York City Residents:To assist in identifying candidates with qualifications matching those required and/or preferred for this role, Insmed uses an Automated Employment Decision Tool (“AEDT”) that employs artificial intelligence to analyze and score information provided in resumes and application materials including, but not limited to, skills, work experience, education, and job-related qualifications. The AEDT does not make final hiring decisions and all final hiring decisions are subject to human oversight and/or review.If you are an applicant for this role and a New York City resident, you have the right to request:A reasonable accommodation, if one is available under applicable law, by emailing View email address on click.appcast.io; and/orAn alternative selection process by emailing View email address on click.appcast.io about the type of data collected, the source of that data, and data retention practices related to the AEDT by emailing us at View email address on click.appcast.io: Research Development Lab - San DiegoType: Full time