Clinical Quality Assurance OPEX Specialist
Takeda Pharmaceutical Company Ltd
 Lexington, MA

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Job Description

  • Support the entire Clinical Quality Assurance team in audit, inspection and compliance related activities
  • Support the execution of the risk-based GCP supplier audit and compliance strategy
  • Assist team in managing GCP consultant auditors
  • Support CQA team with entry of information into audit database
  • Lead periodic review of the CQA audit system
  • Maintain the global CQA Sharepoint site
  • Assist and provide training to CQA team members on audit and compliance databases and CQA Sharepoint site
  • Generate metrics reports from audit and compliance databases for CQA team analysis and reporting
  • Assist GCP supplier team in managing GCP consultant auditors, including identification, qualification, selection, training and management of the ongoing performance of auditors
  • Assist CQA team with provision of material to contract auditors prior to audits
  • Handling the invoices and payment to external auditors
  • Coordinate the development and execution of Scope of Work, Master Service and Quality Agreements for CQA auditors and suppliers
  • Support GCP supplier team on developing and maintaining the global GCP Supplier audit management plan
  • Support GCP supplier quality governance council meetings
  • Escalate systemic and/or critical problems to CQA management
  • Provide miscellaneous administrative support as required.
  • Participate in GCP health authority inspections as required

Locations

Lexington, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time