Roxanne Daugherty-Sim

About Roxanne Daugherty-Sim

Quality and Operational Excellence leader with 20+ years of experience across the pharmaceutical and biotech industries, specializing in GMP commercial quality, external manufacturing, and process improvement. I’ve led quality operations for major product launches, including Syndax’s first commercial oncology therapy, ensuring rapid market delivery through a fully outsourced supply chain.My background spans small molecules, biologics, and cell therapies, with leadership roles at Merck, Johnson & Johnson, Legend Biotech, and Pfizer/Wyeth. I bring a proven track record of managing inspection readiness, developing scalable systems, and driving cross-functional collaboration to deliver results.Certified in Lean Six Sigma and CAPA, and holding a master’s degree in Chemistry, I’m passionate about building strong quality cultures and simplifying complex processes that align with business goals.I thrive at the intersection of compliance and innovation, helping teams bring high-quality, life-changing therapies to patients—faster and smarter

Experience

1. Director, Gmp Quality Commercial

   Syndax Pharmaceuticals

   Apr 2023 — Present

Education

• Texas A&M University

  Master of Science - MS, Chemistry

• Murray State University

  Bachelor of Science, Chemistry

  1993 — 1997

• Lean Six Sigma

  Black Belt, Rath & Strong

  2005 — 2006

• Texas A&M University

  Master of Science, Chemistry

  1997 — 2001

Skills

• Program Management
• Capa
• Data Analysis
• Six Sigma
• Lean Manufacturing
• Analysis
• Quality Assurance
• Quality System
• Dmaic
• Operational Excellence
• Change Control
• Project Management
• Cross-Functional Team Leadership
• Corrective and Preventive Action (Capa)
• Quality Control
• Gmp
• Pharmaceutical Industry
• Fda
• Root Cause Analysis
• Manufacturing
• Process Improvement
• Kaizen