Sr. Staff RIMS Platform Owner
New
Based in United StatesFull-TimeStaff
Salary165,000 - 175,000 USD per year
Apply NowOpens the employer's application page
Job Details
- Experience
- 14+ years (Bachelor's) or 12+ years (Master's/PhD)
Requirements
- Bachelor’s degree with 14+ years of experience, or Master’s/PhD with 12+ years in regulated industry environments
- Proven experience as a systems owner, business analyst, or platform lead within Regulatory Affairs or Quality functions
- Strong knowledge of RIMS and/or eQMS platforms (e.g., MasterControl, Veeva, SmartSolve, Regdesk, or similar)
- Solid understanding of GxP regulations, 21 CFR Part 11, and computer systems validation (CSV) principles
- Experience leading large-scale digital transformation or enterprise platform implementations
- Ability to manage cross-functional stakeholders across regulatory, IT, and business teams
- Strong analytical, problem-solving, and communication skills with executive-level influence
Responsibilities
- Own the end-to-end RIMS platform lifecycle, including requirements, configuration, validation, deployment, and ongoing optimization
- Define and execute the global RIMS roadmap aligned with regulatory strategy and digital transformation goals
- Ensure system compliance with GxP, 21 CFR Part 11, and CSV requirements, maintaining validated state across all changes
- Harmonize regulatory workflows across multiple operating units to ensure consistency and global alignment
- Lead integration of AI, automation, and intelligent agents to improve efficiency and decision-making in regulatory processes
- Partner with Regulatory Affairs, Quality, and IT teams to translate business needs into scalable system capabilities
- Oversee vendor relationships and ensure delivery of platform enhancements and system stability
- Drive continuous improvement initiatives across regulatory systems, data flows, and reporting capabilities
View Full Description & ApplyYou'll be redirected to the employer's site
