QUALITY SYSTEM MANAGER
Exton PA
1-3 Year Contract
This position is responsible for maintaining and improving Quality Systems for the *** 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 *** 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
• Collaborate and provide expert reviews to ensure records, documents, and Quality Systems meet GMP and DI requirements (promote quality, DI, and GMP awareness).
• Support external and internal audits for the *** Americas sites.
• Contribute to the oversight of Quality Systems core responsibilities (track, report, adjust) by trending quality metrics for *** Americas sites.
• Develop and manage processes that ensure the Exton site remains in compliance with global quality polices, regulatory requirements, and industry requirements, including periodic review and consolidation.
Other duties as assigned to facilitate ongoing Quality activities as required, including collaboration with other Quality groups.
Requirements
Education and Experience
• Bachelor’s degree (preferably in science related discipline) preferred
• 5 – 7 years of experience working with Quality Systems (Deviation, Change Control, CAPA, audit, etc.)
• Demonstrated proficiency and experience in working with Quality Systems IT applications
• Training within a regulated Pharmaceutical/biotech/medical device environment
• Understanding and application of CGMP’s (EU, JP, US)
• Detailed knowledge and application with electronic Quality Systems (i.e. TrackWise, Documentum)