4D Molecular Therapeutics · 1 day ago
Associate Director, QA Computer System Validation
United States
Full-time
Remote
Lead/Staff, Director/Executive
$169K/yr - $197K/yr
9+ years exp4D Molecular Therapeutics is a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics. The Associate Director, QA Computer System Validation is responsible for overseeing the validation, compliance, and lifecycle management of GxP computerized systems, ensuring adherence to regulations and supporting business objectives through effective QA leadership.
BiotechnologyLife ScienceGenetics
Responsibilities
Provide QA oversight and support business and CSV activities throughout the lifecycle of GxP computerized systems
Review and approve CSV deliverables, IT change management requests, and quality records (e.g., NCRs CAPAs) to ensure adherence to 4DMT’s internal procedures and policies, and applicable regulatory requirements and standards
Review plans and provide day-to-day QA guidance and support to initial validation, steady state activities and controlled change-related initiatives of GxP systems
Serve as a subject matter expert (SME) in CSV requirements, data integrity controls, and related regulatory requirements / standards, including FDA 21 CFR Part 11, EU Annex 11, GAMP 5, and applicable ICH Guidelines
Develop and/or refine QA and CSV-related procedures and templates
Support audits for qualification and requalification of IT vendors
Collaborate across functions and within Quality to identify areas of improvement and implement enhancements
Support inspection readiness initiatives, audits and regulatory inspections
Other duties as assigned, nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time
Qualification
Required
Bachelor's degree in life sciences, business or related field
9+ years of experience within the biopharmaceutical industry, preferable in both large and small company environments
6+ years' experience in QA CSV
Thorough working knowledge of computer systems validation and computer software assurance
Expertise in 21CFRPart11 and EU Annex 11 regulations, data integrity and GAMP 5 concepts, application and best practices
Hands-on experience in implementing and maintaining data integrity controls
Experience supporting regulatory inspections and audits
Demonstrated ability to apply risk-based approaches to information system selection, testing, implementation and maintenance
Experience working with all levels of management and consulting with key business stakeholders
Strong team player that has a customer service approach and is solution oriented
Attention to detail and the ability to work independently, within a multi-disciplinary team, as well as with external partners and vendors
Excellent written and verbal communication skills; strong interpersonal skills
Company
4D Molecular Therapeutics
4D Molecular Therapeutics designs, develops, and commercializes transformative gene therapeutic products for unmet medical conditions.
51-200 employees
H1B Sponsorship
4D Molecular Therapeutics 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 (1)
2024 (3)
2023 (1)
2022 (1)
2021 (4)
Funding
Current Stage
Public CompanyTotal Funding
$702.5MKey Investors
Cystic Fibrosis FoundationViking Global Investors
2025-11-06Post Ipo Equity· $100M
2025-10-13Post Ipo Equity· $7.5M
2024-02-06Post Ipo Equity· $300M
Leadership Team
David Kirn
Co-Founder & CEO
L
Liansheng Zhu
Sr VP Biometrics and Data Quality
Recent News
2026-01-07
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2025-12-19
Benzinga.com
2025-12-19
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