Insmed Incorporated · 1 day ago
Director, Quality Assurance Systems
San Diego, CA
Full-time
Onsite
Director/Executive
$177K/yr - $242K/yr
10+ years expInsmed Incorporated is a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases. The Director of Digital Systems Quality Assurance is responsible for leading and improving the quality oversight of GxP digital systems supporting gene therapy manufacturing and pharmaceutical development, ensuring compliance with regulatory requirements and internal quality standards.
BiotechnologyMedicalPharmaceutical
Responsibilities
Lead the implementation, validation, and lifecycle management of GxP digital systems within an FDA-regulated (or equivalent global regulatory) environment supporting Gene Therapy programs
Ensure deployed solutions are in alignment with business needs, in compliance with Data Integrity requirements
Provide guidance to team members on software development life cycle, computer validation, and drive a risk-based approach methodology with all stakeholders
Provide oversight to the implementation and validation of GxP software applications/modules and associated interfaces according to business needs and internal procedures (support system upgrades, change control, retrospective validation, software add-on installations where capable)
Work with project teams and business/quality representatives to ensure compliance with regulatory requirements such as FDA, EMEA, PMDA, CAPAs, GxP, etc
Writes SOPs and other quality system documentation, assists other departments with the generation, review and approval and maintenance of such documents
Responsible for the local processes related to QMS, IT Change Control, Computerized System Validation, Data Integrity for electronic systems, and monitoring/auditing of audit trails
Provide support during regulatory inspections and internal audits
Experience with Veeva systems, Labware/Waters/Thermo Fisher software is preferred
Provide leadership and management within the department through a structural process of objective setting, performance appraisal and individual development, including delivery of multiple projects of various complexities
Qualification
Required
Minimum of 10 years of relevant Quality Assurance experience
An advanced degree (MS) and a minimum of 5 years relevant experience will also be considered
BS Degree required or preferred
Experience as QA reviewer of several GMP records and processes: CSV Validation Protocols, Deviations, CAPA, SOPs, etc
Must have excellent communication skills (verbal and written)
Demonstrate ability to manage projects and variable workloads
Highly organized with a strong attention to details, clarity, accuracy, and conciseness
Must successfully exhibit Insmed's five (5) core corporate values: Passion, Accountability, Collaboration, Integrity and Respect; along with any other position specific competencies
Working knowledge of all GxP regulations and reporting requirements, quality systems, Computer System Validation, and quality management tools
Preferred
Experience with Veeva systems, Labware/Waters/Thermo Fisher software
Preferred experience in Data Integrity, 21 CFR Part 11, Annex 11, GAMP 5, SDLC (Agile or Waterfall), CSA
Benefits
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
Company
Insmed Incorporated
Insmed is a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing serious diseases.
1001-5000 employees
H1B Sponsorship
Insmed Incorporated has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (20)
2024 (6)
2023 (14)
2022 (8)
2021 (1)
2020 (5)
Funding
Current Stage
Public CompanyTotal Funding
$4.56BKey Investors
CureDuchenne Ventures
2025-06-11Post Ipo Equity· $750M
2024-05-30Post Ipo Equity· $650M
2023-05-08Post Ipo Equity· $0.5M
Leadership Team
Will Lewis
Chairman and Chief Executive officer
Walter R. Perkins
Chief Technology Officer
Recent News
2026-01-03
Company data provided by crunchbase