Associate Director of Quality Assurance - Quality Assurance
CyberCoders
- New York City, NY
- $166,000-200,000 per year
- Permanent
- Full-time
- Provide strategic leadership to develop, establish, and maintain the QA programs, policies, and procedures to ensure clinical through commercial development lifecycle activities for drug substance and drug product meet cGMP regulatory requirements and guidelines.
- Coordinate investigations with vendors and interdepartmental teams to resolve potential quality issues, mitigate risks, and ensure that appropriate corrective/preventative actions are identified and implemented.
- Support the management and continuous improvement of quality systems, including but not limited to supplier qualification, change management, product complaint management, quality management review, and deviation/CAPA management.
- BS/BA degree with a minimum of ten years experience or, MS/MA with 7 years of experience.
- Experience with 21 CFR Part 820 (Quality System Regulation) and 21 CFR Part 4 (Combination Products)
- Minimum 3 years of experience in CMO oversight is required
- Working knowledge of clinical manufacturing and quality processes, including US and EU regulations and ICH guidelines affecting the pharmaceutical industry