Project Details:This role supports IT-led process improvement and system migration initiatives within a GMP/regulated life sciences environment. The position works cross-functionally with Quality Assurance and Regulatory Affairs teams to support two concurrent, mid-sized initiatives:
- Quality Systems Process Improvement: Own a quality management system enhancement project end-to-end, including current-state and future-state process mapping, requirements gathering, deliverables management, scope control, and risk mitigation. This work is more hands-on project ownership - driving the initiative forward day to day.
- Regulatory Systems Migration: Support a regulatory information management system migration/reconfiguration effort, coordinating closely with external technology vendors and managed service partners. This work leans more toward vendor and stakeholder coordination - ensuring deliverables, timelines, and configurations align across technical teams.
The ideal candidate will be comfortable moving fluidly between structured project management tasks and business analysis work such as requirements elicitation, process documentation, and stakeholder facilitation. This is not a large-scale enterprise program - it's a smaller-footprint, high-visibility role requiring someone who can wear multiple hats and work independently with minimal ramp-up time.
Must Haves:- 5-7+ years of experience in a business analyst, project manager, or hybrid IT role, ideally supporting regulated (GxP/GLP/GMP) business functions
- Direct experience within a GxP-regulated environment, including familiarity with computerized system validation (CSV) concepts, change control, and compliance documentation
- Demonstrated ability to lead or co-lead process improvement initiatives, including current-state/future-state mapping, requirements documentation, and roadmap development
- Experience coordinating with external vendors and/or managed service providers on system implementation, configuration, or migration projects
- Strong stakeholder management skills, with comfort operating cross-functionally between business and technical teams
- Experience supporting manufacturing, quality, or regulatory operations functions (as opposed to clinical operations)
- Ability to manage multiple priorities and shift between analyst-style and PM-style work depending on project needs
- Strong written and verbal communication skills, with the ability to produce clear documentation for both technical and non-technical audiences
