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