Director – IT Compliance
Posted on 8/21/2023
San Carlos, CA, USA • Gaithersburg, MD, USA
Experience Level
Legal & Compliance
IT & Security
  • Our ideal candidate holds a bachelor's degree in information technology, CS, business, finance, engineering, or a relevant field, and has 10+ years' work experience in IT positions with a progression in role sophistication and an emphasis on IT operation, delivery, or development services
  • They must be able to demonstrate they have the technical knowledge to be successful in the role, such as experience working in an FDA regulated environment (GxP), experience with Software Development Life Cycle (SDLC) or relevant framework, and an understanding of processes and financial controls listed above. We'll also look for an excellent communicator with strong project management, problem solving, and analytical skills
  • Implement and maintain IT Compliance and Risk Assessment model
  • Develop and enhance IT Change Management Framework
  • Drive process improvement initiatives within the IT organization
  • Ensure continued compliance with regulatory (SOX, Privacy, HIPPA, 21 CRF Part 11, etc) requirements and internal control standards, serving as central point of data gathering
  • Lead development and maintenance of IT's Computer Validation System (CVS) SOP
  • Collaborate with Corporate Compliance on compliance roadmaps and IT strategy
  • Establish influential relationships to assess and mitigate business and IT risks
  • Develop measurable IT audit plans and policies, SOPs, and IT Controls
  • Work with 3rd party vendors to ensure effective and auditable controls are in place
  • Evaluate training needs and deliver content to support the control environment and foster a compliance & risk aware culture