Scientist, Quality Systems

Key Responsibilities

• Foster continuous improvements in system practices
• Perform independent research of regulatory requirements
• Evaluate and implement standardized compliant practices
• Monitor regulatory trends and identify industry best practices
• Perform on-site and TEAMs training
• Review site SOPs and protocols
• Support global inspection preparedness
• Develop and manage IT platform solutions
• Conduct purpose driven meetings with site SMEs
• Develop health-based metrics for cleaning validation
• International travel (30%)

Requirements

Education

Bachelor's degree minimum, Master's or Ph.D. preferred

Experience

4-7 years with Bachelor's, 2 years with Master's, 0-2 years with Ph.D.

Required Skills

• Knowledge of cGMP regulations
• Regulatory interpretation
• Independent decision-making
• Advanced computations
• Statistical analysis
• Technical writing
• Problem-solving
• English language proficiency
• Pharmaceutical calculations
• Leadership and communication
• Project management