NewAmsterdam Pharma Corporation

Director

• Responsible for managing the Quality Control tasks and reports into the NAP Quality Team.
• Review CMO QC laboratory operations, ensuring compliance with regulations such as FDA, EMA, Health Canada, and Rest of Work regulatory requirements as well as Global regulatory and ICH guidelines.
• Support analytical development in a quality role; ensuring data integrity; creating, reviewing and approving technical documents (such as stability reports, method validation and method verification protocols and reports and final analytical release data).
• Analyze data and metrics relate to quality control to identify trends, patterns, and areas for improvement.
• Establish and maintain relationships with suppliers and vendors to ensure compliance with quality control standards.
• May be a subject matter expert for regulatory submissions and inspections related to Quality Control tasks and data.

Director, Quality Control