Contract research and manufacturing company in suburban Cleveland is searching for a Quality Assurance Manager provide quality oversight and support to the site's technical operations group for the manufacture and characterization of non-clinical, clinical and commercial products in compliance with GMP and GLP guidelines.
 
Requirements for QA Manager:
 

• Bachelor's degree in a technical or scientific discipline
• 7+ years' experience in the pharmaceutical / biotech industry
• 5+ years' experience in Quality Assurance supporting manufacturing and characterization of small molecule drug substance for clinical and commercial use in a contract environment.
• Working knowledge and technical understanding of the manufacture and testing of small molecule drug substance and drug product
• Knowledge of GMP and GLP principles with respect to FDA and EMA regulations and guidelines
• Knowledge of drug development process
• Experience in deviation investigations, root cause analysis, risk assessment and developing corrective action plans
• Experience in data integrity / 21CFR Part 11 Compliance
• Experience is process validation, analytical method validation and equipment qualification
• Excellent communication and documentation skills
• Experience managing multiple priorities and quality assurance staff