Senior Manager Corporate Quality & Compliance

This Biopharmaceutical company focuses on serving patients with severe and ultra-rare disorders through the innovation, development and commercialization of life-transforming therapeutic products. A global leader in complement inhibition, and has developed and markets products as a treatment for patients with PNH and aHUS, two debilitating, ultra-rare and life-threatening disorders caused by chronic uncontrolled complement activation.

The Position

  • Assess audit needs and independently develop audit agendas and plans for both GxP/Pharmacovigilance practices
  • Disseminate the annual audit schedule to auditees and work collaboratively on audit schedules and timing
  • Lead collection and reporting of performance metrics
  • Lead and/or co-lead in the audits per plan through, responsible for agenda, audit, close out and report
  • Schedule, prepare and conduct global audits in collaboration with audit team as per plan
  • Escalate the critical observations to management
  • Prepare, approve and distribute the audit reports
  • Review the site CAPA plan for appropriateness.
  • Act as a key liaison between local operational groups and Corporate Quality for Regulatory Inspections.
  • Involvement with global inspection readiness as requested
  • Partner with local operational and PV affiliate groups to foster a proactive approach to compliance

The Person

  • 8 years+ of hands-on Quality Assurance / Compliance auditing experience in pharmaceutical/biotech industry.
  • Thorough knowledge of applicable global GxP requirements required.
  • Experience in a broad range of Pharmaceutical activities and Quality systems.
  • Demonstrated computer skills

To learn more apply on line or call Shane Browne on +353 1 6321865.

Salary: On Application Location: Dublin City Centre