Director of Information Technology
19 hours ago
- Function as the internal advisor and business partner in assessing current technology needs and creating an IT strategy and framework for the organization, focusing on a cloud-first, secure, GMP-compliant approach
- Oversee and lead all activities and solutions associated with the collection, optimization, transfer, and quality of data collected from internal and external sources
- Oversee IT security and governance, including data integrity, security, and audit trail functionality for validated systems and ensuring protection against unauthorized access, breaches, or theft, while adhering to industry regulations (e.g. FDA 21 CFR Part 11, GMP, GxP)
- Implement technical solutions, tools, and process improvement strategies, including the installation, configuration, and maintenance of software, hardware and network systems in compliance with company policies and industry regulations
- Manage external IT vendors and service providers, driving performance
- Provide employee/user life cycle IT support and manage evolving needs
- Ensure internal alignment with functional goals, objectives, priorities, and timelines
- Bachelor’s Degree is required (ideally in computer sciences or related field), certifications and/or advanced degrees preferred
- Minimum of 5 years of relevant experience, including prior leadership experience scaling IT functions within early-stage biopharma organizations that are transitioning into the Clinic
- Prior experience in and a strong understanding of what is required in a GMP/GxP environment
- Advanced knowledge of Cloud-based infrastructure architecture and services
- Hands-on experience with the validation of software, hardware, laboratory, production, and manufacturing systems
- Exceptional leadership, management, and communication skills with strong acumen in directing internal stakeholders and leading external partners and vendors
- Ability to communicate ideas in both technical and user-friendly language with the demonstrated ability to teach and share knowledge with others in a clear and concise manner
- Solutions-focused and customer service-oriented approach
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