Project Manager
Pharmavise Corporation · Indianapolis, IN · 1 mo ago
HybridProject ManagementContract
Key Responsibilities
- Lead global GxP Quality transformation programs across multiple sites and functions
- Drive QMS harmonization and enterprise process standardization initiatives
- Support inspection readiness modernization and alignment with FDA expectations
- Optimize CAPA and Deviation lifecycle processes through structured improvement efforts
- Deploy Lean methodologies within Quality functions to improve efficiency and reduce waste
- Support implementation or enhancement of digital Quality systems (Veeva QMS, TrackWise, MasterControl)
- Lead initiatives involving digital logbooks, eBR, MES integration, and Quality data analytics
- Enable development of Quality Maturity metrics, dashboards, and executive reporting tools
- Drive automation and AI-enabled improvements in Quality workflows where applicable
- Manage cross-functional stakeholder engagement across Quality, Regulatory, Manufacturing, and Technology
- Identify and mitigate program risks in a global, regulated environment
- Prepare executive-level updates and KPI dashboards for senior leadership
Required Qualifications
- 8–10+ years of experience in pharmaceutical and/or medical device industries
- Bachelor’s degree in a scientific, life sciences, or health-related field
- Strong GxP knowledge (GMP, FDA Quality Systems Regulations)
- Experience leading enterprise-level Quality or QMS transformation initiatives
- Experience supporting global or multi-site programs
- Demonstrated Lean deployment or process improvement experience
- Strong stakeholder management and executive communication skills
- Ability to work onsite in Indianapolis, IN