Job Details

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