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Quality Manager

Newark Metro Area, NJ

Post Date: 03/16/2017 Job ID: JN -032017-18609
The individual in this position will perform activities related to development and management of procedures, management of corrective and preventive action plan follow-up, and management of timely reporting and maintenance of role-based training plans to ensure quality management of process documents and training materials.

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 development/revision and reviews of 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
Liaise with Clinical QA to ensure quality management

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

Maintenance of Training Plans
Support maintaining role-based training plans
Ensure that trainings are updated in the Learning Management System and match the role-based training plans
Generate or support generation of training materials inclusive of relevant user guides or job aides that define data collection and reporting standards
Monitor training effectiveness and update materials/re-train as needed to support continuous improvement and meet business needs

Skills/Knowledge Required:
BA/BS in life sciences or equivalent with at least 3 years of experience in quality assurance administering/managing procedures and training programs; global experience preferred
Strong understanding of regulations and guidelines related to quality systems and documentation
Strong attention to detail and ability to resolve issues collaboratively
Ability to interact across multiple functional areas, as well as countries, with keen attention to cultural differences

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