Sr. R&D IT Manager

The role

The Sr. R&D IT Manager provides hands-on technology leadership and serves as the IT System Owner for assigned GxP and business-critical applications. This role manages the technical ownership, implementation, administration, and lifecycle of systems supporting R&D, Technical Operations, and other clinical and quality organizations.

What you will do

• Serve as the IT System Owner for assigned GxP and business-critical applications.
• Partner with Business Process Owners to translate needs into technology requirements.
• Partner with Quality Assurance and IT Computer System Validation on GxP applicability and validation strategy.
• Lead complex system implementations, upgrades, integrations, and migrations.
• Administer or oversee application configuration, security roles, and technical components.
• Maintain documentation of application architecture, data flows, and vendor support.
• Ensure controls for electronic records, signatures, and data integrity.
• Serve as the senior IT escalation point for complex application and integration issues.
• Maintain inspection-ready documentation and support audits and regulatory inspections.
• Lead and manage contractors, consultants, and vendor resources.

Required qualifications

• Bachelor’s degree in Computer Science, Information Systems, Software Engineering, or a related technical discipline
• 8+ years of progressive experience with a Bachelor’s degree or 6+ years with a Master’s degree supporting, implementing, administering, validating, and managing business applications in a pharmaceutic
• Hands-on experience serving as the IT System Owner, application owner, system administrator, technical lead, product owner, or comparable role for multiple regulated or business-critical applications.
• Experience with the full lifecycle of GxP computerized systems.
• Demonstrated experience leading complex GxP technology initiatives.
• Experience collaborating with Business Process Owners, QA, CSV, IT infrastructure teams, vendors, and implementation partners.
• Demonstrated experience directing contractors, consultants, implementation partners, or managed-service resources.
• Strong understanding of IT System Owner responsibilities and GxP computerized system controls, including 21 CFR Part 11, EU Annex 11, GAMP 5, ALCOA+ principles, and risk-based Computer Software Assura
• Ability to understand application architecture, integrations, data flows, hosting models, security controls, technical dependencies, and support requirements.
• Ability to balance business needs, compliance requirements, technical risks, operational support, security, and cost.
• Strong project leadership, technical problem-solving, vendor management, documentation, and stakeholder communication skills.

Nice to have

• Advanced degree or relevant professional certification
• Experience with GxP systems and interfaces, IT QA, or Computer System Validation
• Working knowledge of programming, scripting, databases, workflow automation, or low-code technology
• Experience using Microsoft Copilot or other approved artificial-intelligence tools

About the company

4D Molecular Therapeutics (4DMT) is a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics. The company is a late-stage clinical gene therapy company advancing a potentially transformative pipeline toward its first Biologics License Application (BLA) and commercial launch.