Regional Quality Manager (m/f)

  • Establish & maintain a management system acc. to ISO 9001/14001 & cosm. GMP to cover business operation
  • Ensure manufacturing process control is in place within own units as well as tolling operations
  • Coordinate all activities related to quality audits (internal/external) including calendar and interfaces
  • Ensure standards applied to BU ICS NorAm are aligned with Global BU and Regional QMS
  • Actively participate on BU activities related to customer, suppliers/vendors and business partners
  • Define, implement and maintain required lab structure for QC activities according to business needs
  • Manage laboratory personnel including deliverables of continuous operation and people development
  • Ensure quality SAP related information is in place and kept up-to-date including master data
  • Ensure that improvement actions and optimizations follow the requirements of Management of Change
  • Ensure quality related actions (e.g. from audits or internally defined) are completed on a timely manner
  • Lead projects and improvement initiatives throughout the entire scope of the BU regional operation
  • Establish, implement and maintain professional investigation and root cause analysis when failure occurs
  • 3 years experience with Quality aspects in industrial processes
  • Experience in leading c-GMP, FDA or FIFRA audits, understanding of Quality assurance in an FDA, DEA regulated environment
  • 3+ years managing people
  • Statistical analysis, Lean / six Sigma training, certified auditor for ISO and / or cosmetic&GMP
  • Bachelors Degree in a Science related or Quality discipline

» Job description

82152 North Carolina - Mt. Holly [USA]

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