Senior QA Professional
1 day ago
We are seeking a skilled Senior Manager, GMP Global QA to join our Global QA team at Y-mAbs Therapeutics. As a member of our organization, you will contribute to the development and commercialization of cutting-edge therapies to treat various cancers.
Job OverviewThe Senior Manager, GMP Global QA will be responsible for maintaining and improving our company's Quality Management System. This includes ensuring adherence to regulatory requirements and industry standards, as well as overseeing employee training activities, change management, and the maintenance of Product Specification Files.
Responsibilities:
- Maintenance of SOP system
- Oversight of employee training activities
- Change management
- Maintenance of Product Specification Files
- Assessment of quality events (deviations, root cause investigations, CAPA, OOS)
- Preparation of Quality Management Reviews
- Quality Risk Management activities
- Hosting of regulatory GMP inspections and audits by external parties
- Self-inspections
Requirements:
- 5+ years of experience in pharma/biotech industry in Quality Assurance, GMP
- Thorough knowledge of cGMP requirements
- Robust quality culture
- Comprehensive experience in quality systems (handling of quality events, change management, training, vendor management)
- Knowledge of manufacturing processes for biologics and sterile products is an advantage
- Proficiency in English
- Strong skills in writing and handling of documentation
- Good computer skills, experience with EDMS (knowledge of Veeva is an advantage)
- Good planning, prioritization and task completion abilities
- Good communication skills, both internally and with external parties
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