Cheryl Paprota

About Cheryl Paprota

Accomplished, compliance minded individual with a comprehensive understanding of Quality Systems, cGMPs, CFR, and FDA Guidance documents. Successfully lead operational improvements focusing on continuous improvement and business driven initiatives. Experienced in developing and implementing compliance processes and related quality functions to support outsourced activities. An influential leader and site change agent possessing the ability to adapt to varying environments, with proven success in forging strong collaborative relationships with internal and external business partners.

Experience

1. Director, Quality Operations Us and Analytical

   Intercept Pharmaceuticals

   Jun 2022 — Present · Morristown, NJ, US

   Oversee quality operations for third-party vendors in commercial, development, and clinical spaces, including batch disposition, deviations, change controls, and issue resolution.• Act as a single point of contact for quality oversight, ensuring compliance with regulations and standards.• Lead audits, managed complaints, and implemented quality technical agreements to maintain high standards.• Achieved successful resolution of quality issues, contributing to the overall success of Intercept Pharmaceuticals.

Education

• Lycoming College

  Bachelor's degree, Chemistry

Skills

• Change Control
• Pharmaceutics
• Quality Assurance
• V
• Regulatory Affairs
• Uv/Vis
• Assay Development
• Quality Control
• Gmp
• Standard Operating Procedure (Sop)
• Regulatory Submissions
• Testing
• Good Laboratory Practice (Glp)
• Capa
• Pharmaceutical Industry
• Sop
• Fda
• Quality System
• V&V
• 21 Cfr Part 11
• Validation
• Analytical Chemistry
• Verification and Validation (V&V)
• Strategic Planning
• Hplc
• Corrective and Preventive Action (Capa)
• Glp
• Research and Development (R&D)
• Process Improvement
• Product Development
• Technology Transfer
• Manufacturing