Job Description
Our Fortune 500 global Pharmaceutical client is seeking an experienced Global GxP Quality Project Manager.
Job Summary:
The Global GxP Project Manager will support enterprise-level Global Quality Transformation and Technology initiatives. This role operates within Global Quality leadership and supports strategic transformation efforts across Quality Culture, Quality Maturity Systems, and global QMS modernization. The scope is global and not site-specific. The organization requires a structured, transformation-driven PM who understands regulated environments, Lean deployment, and digital Quality enablement.
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
Provide structured governance, PMO alignment, and milestone tracking
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
Preferred Qualifications:
PMP certification
Lean certification (Lean Six Sigma Green Belt or Black Belt preferred)
Experience with Veeva QMS, TrackWise, or MasterControl
Drug and medical device experience
Experience supporting inspection readiness or regulatory scrutiny
Other Details:
Schedule: Full Time
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