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.
- 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
- 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