Quality Systems Manager
Bryllan LLC
 Brighton, MI

The Quality Systems Manager is responsible for the developing, maintaining and ensuring the execution of the quality system through the use of audits, software and metrics.

Quality Systems Responsibilities:

  • Development and reporting of site metrics
  • Coordinate management review meetings for each/all suites
  • Management of Compliance Programs
  • Supplier Management
  • Supplier approval process including coordination and execution of on-site audits
  • Approved supplier list
  • Internal Audit Program
  • Coordination and scheduling
  • Tracking of audit commitments
  • Support for external audits / regulatory inspections
  • Lead for back room (war room) activities
  • Tracking of audit commitments
  • Management of Complaint System
  • Execute / oversee customer complaint investigations for all manufacturing suites
  • Support Annual Product Reviews
  • Provide review and data as required to support customer APR requirements
  • Process, System, and Documentation Continuous Improvement and Administration
  • Support CI existing and new processes, systems and documents utilizing inputs from stakeholders to increase compliance, efficiency and/or effectiveness of existing processes / systems
  • Manage the archiving of controlled documents: obsolescence, control of master and original documents
  • Manage the document library, archiving of documents
  • Maintain electronic versions of master documents
  • Track completion of periodic SOP review requirements
  • Administration of Training Program
  • Maintain electronic matrix for tracking
  • Maintain paper copies of training records in QDC

Work Experience and Education Requirements

  • Minimum of 5 years' experience in pharmaceutical manufacturing
  • 5 or more years of experience in quality and/or quality systems
  • Minimum qualification of a four-year Degree in engineering, quality or related field.