Quality Systems Manager
Location: Exton, PA
Duration: 12 Months
Job Description :
This position is responsible for maintaining and improving Quality Systems for the Company Americas Region to ensure on-going compliance to applicable compendia, GMP's, and Regulatory guidance. The Quality Systems include quality risk management, documentation, global and local auditing, health authority inspection management, training, event management (deviations, complaints, CAPA), and change control (global and local). The role will interface with Quality System personnel in other Company sites.
The person in this position will serve as a subject matter expert (SME) for GMP and Data Integrity (DI) requirements. Must effectively work as a team with internal customers, peers, and management through effective oral and written communication. Must evaluate the compliance of records, documents, and Quality Systems to ensure that the site is operating per GMP and Data Integrity requirements.
Essential Functions:
Other duties as assigned to facilitate ongoing Quality activities as required, including collaboration with other Quality groups.
Required Education and Experience:
Technical:
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