Global Supplier Quality Manager

  • Contract
  • Cork

Website Ref:TPM04661

Summary:
A Global Supplier Quality Manager is required for a biopharmaceutical company in Cork. The incumbent will support and maintain Quality oversight for Supplier Quality systems.

Responsibilities:

  • Provide Quality Assurance review and/or approval for Supplier related activities impacting GxP operations, including Change Requests, Deviations, and associated documentation.
  • Compile Supplier Performance metrics; including metrics for supplier changes, deviations, and other measures of supplier performance.
  • Lead and participate in cross-functional Supplier Quality meetings.
  • Represent Global Quality in multi-departmental meetings & project teams.
  • Participate in inspection preparation and participate in internal audits and regulatory inspections.
  • Maintain current knowledge of industry standards and regulatory requirements for products developed or manufactured by our client and for supplier related approaches utilized by them.
  • Other duties as assigned.

Qualifications & Experience:

  • B.A. or B.Sc. in a technical discipline (physical or biological sciences).
  • 8+ years experience in a GMP regulated environment, with exhibited knowledge and proficiency working within quality systems preferred.
  • Organizational and management skills, with ability to effectively plan, schedule, execute, and track complex projects.
  • Ability to speak, present data, and defend approaches in front of audiences and inspectors.
  • Ability to comprehend technical information related to regulatory expectations.
  • Experience with cross functional project management.
  • Experience in participation in regulatory inspections, with experience in presenting or defending departmental functions in audits or regulatory inspections preferred.
  • Desired experience with TrackWise and/or Veeva QMS.
  • Experience working with international project teams desired.

To apply for this job email your details to patricia.arrue-elorza@tandempm.ie.