GMP Quality Assurance Manager
1 day ago
At Y-mAbs Therapeutics, we are dedicated to becoming a world leader in developing innovative radioimmunotherapy and antibody-based oncology products. As part of our Global Quality Assurance team, you will play a crucial role in maintaining and continuously improving our company's Quality Management System.
About the RoleThe Senior Manager, GMP Global QA will be responsible for ensuring adherence to regulatory requirements and industry standards. This includes overseeing employee training activities, change management, and the maintenance of Product Specification Files. Additionally, you will assess quality events, prepare Quality Management Reviews, and conduct Quality Risk Management activities.
Key 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
Required Skills and Qualifications:
- 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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