Manager, Clinical Quality
Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries – and growing we look for talented people to grow our business, advance our science and contribute to our unique culture.
Summary/Scope:
The individual in this position will perform activities related to development and management of procedures, management of corrective and preventive action plan follow-up, management of timely reporting and maintenance of role-based training plans.
Key responsibilities include, but are not limited to, the following:
Development and Management of Procedures/Tools/Templates/Forms
•Develop processes and tools such as author guidelines and process flows and support author training to ensure timely and quality procedure preparation
•Manage procedures, forms and templates related to clinical trials to ensure quality and timeliness
•Track metrics and prepare reports for management related to cycle times and quality
•Support internal audits related to clinical processes and systems
Management of CAPAs
•Support internal audits related to clinical processes and systems, collect documents and prepare communications to individuals impacted regarding timing and requirements
•Manage CAPA follow-up by working closely with assigned business owner to ensure timely completion…cont.
See more at http://www.hirelifescience.com/manager-clinical-quality/berkeley%20heights-nj-07922-693982/?p=p&submission=2
