QA Engineer

• Own the Global DI Program that ensures compliance to regulatory requirements at all Pharmaceutical Services Group (PSG) sites
• Drive practical improvements and develop and monitor Key Performance Indicators to measure the effectiveness of the program
• Stay current on global regulations and expectations and industry trends related to data integrity
• Update global policies and procedures and other program elements to maintain a state of regulatory compliance
• Help sites resolve challenges in program implementation, instrument/equipment remediation, etc.
• Lead a Global Community of Practice for information sharing between sites
• Assist sites with data integrity risk assessments and mitigation/remediation plans
• Analyze metrics and address trends to Site Quality Heads and General Managers and Division Quality VPs
• Use PPI (Practical Process Improvement) methodology to develop or improve processes that enable sites to improve documentation and data integrity requirements
• Support sites in explaining the Data Integrity Program for regulatory and client audits as needed
• Develop training content that global and site training coordinators can deploy
• Take on other duties/projects as assigned to support the Global Quality Compliance Team as required

Director, QA Data Integrity

Senior Software Engineer – Quality Assurance Development

QA Lead

Senior Software Application Tester

Quality Engineer