Rae Ann Ludwig

About Rae Ann Ludwig

Experienced Quality Systems Manager and ASQ Certified Quality Auditor with a strong foundation in Clinical Research, Quality Assurance, and Project Management across pharmaceutical, biotech, consumer health, and medical device sectors. Proven track record of driving compliance, operational excellence, and continuous improvement in regulated environments.Currently serving as a Quality Supplier Auditor with 3 years of experience conducting GMP and ISO-compliant external supplier audits. Also bring 4.5 years of experience conducting internal GMP quality audits to ensure alignment with regulatory standards and internal quality requirements. Actively involved in back room coordination during regulatory inspection audits, supporting real-time documentation retrieval, response strategy, and cross-functional alignment.As a former Document Control Manager, served as System Administrator for electronic document management systems (EDMS), including Qumas and MasterControl—responsible for configuring users, roles, hierarchies, and training workflows to support GxP documentation standards.Skilled in leading and facilitating cross-functional initiatives such as Human Error Reduction programs, software validation (system upgrades and migrations), and Johnson & Johnson Production System (JJPS) projects. Known for adaptability, attention to detail, and a collaborative approach to solving complex quality challenges.

Experience

1. Principal Quality Associate, Supplier Audits

   Catalent

   Apr 2025 — Present

   Internal Quality System Audits and Quality Supplier Audits• Participate in Regulatory Agency audits• Maintained Inspection Readiness

Education

• DeSales University

  BA, Business Management

  2004 — 2009

Skills

• Design Control
• Requirements Analysis
• Validation
• Biotechnology
• Budgets
• Iso 13485
• Pharmaceutical Industry
• Sop
• Fda
• Management
• Cross-Functional Team Leadership
• Quality Assurance
• Gxp
• Quality Auditing
• Training
• Regulatory Affairs
• Lifesciences
• Internal Audit
• Quality Control
• Gmp
• CRO
• Document Review
• Lims
• Gcp
• Biopharmaceuticals
• Process Improvement
• Sap
• Regulatory Submissions
• Quality System
• V&V
• Document Management
• 21 Cfr Part 11
• Change Control
• Coaching
• Edoc
• Quality Management
• Microsoft Office
• Project Management
• Computer System Validation
• Troubleshooting