Associate Director - Global Documentation and Change Management
Location: New Jersey, Greater New York Area
A rapidly expanding Biotech manufacturing firm is looking to hire an Associate Director for Global Documentation and Change Management. This is a growth hire due to recent funding and expansion plans. This person will both on-board new employees as well as cross -train existing ones. Moreover, they will be responsible of creating new methodologies and strategies that identify curriculum, training format, and evaluate training effectiveness.
This firm is one of the few in its space to focus directly on manufacturing, both commercial and clinical, in cell and gene therapy, a rapidly growing technology in the pharmaceutical space. As a pioneer in this sector, they have extensive client relationships, here in the US as well as in Europe and Asia.
- Responsible for the development of management processes for GxP documents
- Assists development of the overall global Quality Standards of the company
- Leads the development of reporting those Quality Standards
- Manages document change request system at global and regional level
- Develops the standards and guidelines for change control inputs
- BA/BS in the Life Sciences is required; MS in Life Sciences is a plus
- 7+ years' experience in Document Management and Control
- 3+ years in Change Management in FDA regulated, GxP related industry
- Knowledge of ICH Guidelines and FDA cGMPs Guidelines
- Comprehensive understanding of document control principles, data integrity principles, and good documentation practices (GDP)
If you are interested, please send your resume to my email: