Senior Manager MQA

LocationCopenhagen, Denmark


Key Responsibilities as an active member of the client's Quality Leadership Team (QLT) include:

  • Performance management within the department (PMP process)
  • Manage, train, develop and motivate personnel
  • Prioritize different tasks within the team
  • Manage handling of Complaints, Reprocess, Deviation, Change and Recalls within the Department
  • Responsible for robust stakeholder management with all relevant parties
  • Responsible for an adequate and qualified staff to attend to the field of responsibility of the functions
  • Budget responsible including follow-up on expenses and investments in the department
  • Run and manage MQA (Manufacturing Quality Assurance) for API and FDF in a cost-efficient manner ensuring that continuous improvement initiatives are implemented
  • Ensure effective API and FDF release processes
  • Reporting of release status and quality metrics within area of responsibility
  • Ensure MQA support to site related projects as per plans
  • Secure GMP and regulatory compliance
  • Approval of relevant GMP-related documentation
  • Elaboration of APQR (Annual Product Quality Review) for MQA
  • Maintain compliance with regulatory requirements, guidelines and GMP-trends
  • Ensuring Quality oversight in API and FDF production
  • Ensuring QP oversight according to EU legislation and Annex 16
  • Support to Global Technical Support regarding customer inquiries and to Regulatory Affairs in connection with Quality Issues
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