Cleveland, OH 44101
Job DescriptionQuality Assurance (QA) Manager with in-depth experience in small molecule drug substance development, manufacturing and characterization in compliance with GMP and GLP guidelines. Reporting to the General Manager, the QA Manager will provide Quality oversight and support to the Technical Operations group for the manufacture and characterization of non-clinical, clinical and commercial products in compliance with GMP and GLP guidelines. The QA Manager will be accountable for establishing and driving Quality initiatives, maintaining/improving quality infrastructure and participating where needed on various CMC related project teams. The QA Manager will be accountable for assuring compliance with the companies Quality System, identifying/driving quality system improvement, quality oversight at the project level and generation of metrics to drive continuous improvement.
- Responsible for the review and approval of quality documentation including quality agreements, project protocols, validation plans, batch records and associated analytical data related to the manufacture and characterization of drug substances and drug products
- Responsible for the disposition of drug substances and drug products
- Review and approval of deviations and resulting investigation reports, corrective actions and/or preventive actions for adequacy and logic of root cause analysis, and impact to both quality and regulatory commitments.
- Perform in-study and in-process audits to assure compliance of operational activities
- Responsible for supplier and material qualification supporting GMP manufacturing,
- Establish and administer program to assure data integrity
- Administer Quality Management System databases for change control, deviations, and CAPAs
- Management of a 3 to 5 person QA staff
- Responsible for corporate archives and document control
- Establish and administer corporate training program.
- Manage inspections by Regulatory Authorities
- BS or equivalent in a technical discipline and a minimum of 7-10 years of experience of in the pharmaceutical/ biotech industry
- Must have at least 5 years of 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