About the Role:
Reporting to the Associate Director, Quality - Analytical, the Senior Analyst is responsible for providing Quality Assurance oversight of internal and external Quality Control activities supporting Gene Therapy programs. This role ensures analytical testing, stability programs, and laboratory operations are conducted in compliance with cGMP regulations, global health authority guidelines, regulatory filings, and company procedures.

You will serve as the primary QA point of contact for assigned products or laboratory functions, independently managing routine quality oversight and laboratory record approvals while escalating complex, high-risk, or strategic matters to QA leadership as appropriate. This position requires a strong quality mindset, technical understanding of analytical testing, and the ability to apply risk-based decision-making to maintain compliant, inspection-ready operations aligned with product lifecycle requirements.

What You'll Do:

In this role, you'll have the opportunity to provide QA oversight of internal and external QC laboratory operations to ensure compliance with cGMP regulations and global health authority requirements. You'll also:

• Serve as the QA point of contact for assigned products, stability programs, and/or laboratory functions.
• Review and approve release and stability analytical testing documentation, raw material qualifications, method validation protocols and reports, and equipment qualification documentation. Review and approve SOPs, deviations, investigations, CAPAs, change controls, and supplier notifications.
• Provide QA oversight of OOS, OOT, and atypical laboratory investigations to ensure scientifically sound root cause analysis and compliant documentation.
• Assess quality impact of laboratory events and escalate high-risk, cross-functional, or potentially regulatory-impacting issues to QA management as appropriate.
• Review and approve equipment qualification, calibration and maintenance program.
• Ensure compliance with data integrity requirements, including 21 CFR Part 11 and Annex 11.
• Ensure analytical methods and documentation remain aligned with regulatory filings and current product registrations.
• Track record status and analyze laboratory metrics and analytical trends to support compliance and continuous improvement. Review and approve internal and external analytical method qualification/validation.
• Participate in cross-functional discussions to provide quality input and risk-based recommendations.
• Support internal and external audits, regulatory inspections, and supplier-related quality activities as needed. Partner with QC to drive continuous improvement initiatives and maintain audit readiness.

Who You Are:

You have a minimum of a Bachelor's degree in in Chemistry, Engineering, Life Sciences, or a related discipline along with 5+ years of experience in Quality Assurance experience within the pharmaceutical or biotechnology industry, preferably supporting Quality Control operations. You are or you have:

• Experience supporting Gene Therapy and/or biologics experience, a must.
• Strong knowledge of cGMP regulations and global laboratory compliance standards (FDA, EMA, ICH).
• Experience with deviations, investigations, CAPAs, change controls, and method validation oversight.
• Working knowledge of data integrity principles and regulatory expectations, including electronic records and laboratory systems compliance.
• Familiarity with risk management tools (e.g., FMEA) and risk-based decision-making.
• Solid understanding of QC laboratory operations and analytical testing.
• Familiarity with analytical techniques such as HPLC/UPLC, CE-SDS, Cell Based Potency Assay, ddPCR, ELISA, Microbiology safety assay and related methodologies.
• Experience with quality and laboratory systems (e.g., Veeva, LIMS, Chromeleon, BMRAM or equivalent).
• Proficiency in Microsoft Office applications (Word, Excel, PowerPoint, Outlook).
• Strong analytical thinking and sound judgment. Highly organized with strong attention to detail, accuracy, and clarity.

Where You'll Work

This role is based out of our San Diego office and requires full-time, in-person presence to support hands-on collaboration, access specialized equipment, and/or operational needs.

Travel Requirements

This role requires occasional travel (approximately up to 20%).

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Pay Range:
$100,000.00-126,500.00 Annual

Life 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 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
• Employee resource groups, service and recognition programs, and meaningful opportunities to connect, volunteer, and give back

Eligibility 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.