Viatris

Viatris

Senior Manager, R&D and Regulatory Systems

United States Remote Office · Senior

Sponsorship not specified$95k-$193kDetected 16 days ago
GCPAgentic AIComplianceProject ManagementFDA RegulatoryLeadershipCommunicationGxP

About the role

  • Viatris is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address healthcare needs globally.
  • The salary range for this position is $95,000.00 - $193,000.00 USD.
  • Viatris is an Equal Opportunity Employer.

Responsibilities

  • Manage the successful completion of IT projects from conception to implementation ensuring successful project delivery in scope, on schedule and within budget.
  • Communicate project status and manage issues/risks in a timely manner and promptly escalate issues to leadership.
  • IT platform owner for Regulatory intelligence and publishing systems and other assigned systems, collaborating with IT teams to maintain deployed systems including managing break fixes, incident management work and system security.
  • Application technical lead supporting the successful implementation, system lifecycle, evolving enhancements, requirement analysis, design, configuration, data migration, system integration, testing and validation activities.
  • Drive compliance with the IT Quality processes and Viatris SDLC processes, including the IT change management and quality/testing process for assigned projects/systems. Create/Review lifecycle documentation for assigned systems.
  • Support vendor relationships for assigned systems, ensuring system issues are communicated promptly to leadership.
  • Provide strong working knowledge of technical capabilities used to support R&D and regulatory business processes and deliver industry leading processes.
  • Drive compliance with the IT Quality processes and Viatris SDLC processes, including the IT change management and quality/testing process for assigned projects/systems.
  • Create/Review lifecycle documentation for assigned systems.
  • Establish and maintain strong relationships with customers.

Requirements

  • 5+ years of previous experience as IT platform owner and people leadership required.
  • 8+ years of project management experience in the life science domain.
  • Knowledge of GCP, EMA + FDA regulations and other regulatory compliance standards.
  • Hands-on experience with validated GxP environments including documentation and change management required.
  • Broad technical knowledge, including hands on experience designing and implementing system integrations as well as working with migrations and SaaS in a regulated environment.

Nice to have

  • Bachelor's degree in science, IT, or a relatable field required.
  • Advanced degrees are a plus.
  • Preferred hands on experience in Agentic AI and python.

Compensation

  • The salary range for this position is $95,000.00 - $193,000.00 USD.

Benefits

  • Monitor emerging industry and health authority requirements to assess business and system impact and develop the requirements to ensure compliance.
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This listing is sourced directly from Viatris's careers page and normalized into a canonical job model.