Our client is an international biopharmaceutical drug discovery and development company, headquartered in Dublin, Ireland, focusing on new medicines for diseases which have a high unmet need.
They are currently looking for a Senior QA Audit Manager with a proven track record in Quality Assurance; leading GCP audits and overseeing compliance with all GCP, GLP and GMP requirements. The successful candidate will be involved in maintaining, developing and continually improving the organisation’s Quality Management System and ensuring a Quality culture is present throughout the organisation.
• Lead and contribute to the improvement and maintenance of the QMS.
• Plan and conduct routine and risk-based QA audits and inspections of the quality system, and clinical trial sites, on an international basis in order to provide assurance of compliance with our clients QMS, relevant standards, regulations and guidelines.
• Ensure that audit results and other quality information are formally and consistently recorded and reported and that corrective actions/preventive actions are documented effectively.
• Oversee the documentation and tracking of QMS activities, including deviations and change controls, and the implementation of corrective actions.
• Verify that the quality system is being implemented both internally within the organisation and externally with outsourced vendors.
• Maintain and develop the vendor oversight process, and perform vendor audits and assessments.
• Perform staff training regarding the Quality system, applicable standards, and regulations and on external audits/inspections.
• Support other aspects of the business as needed.
• As a member of staff, the employee is expected to embrace and contribute to their culture of process improvement.
• Travel (approximately 10-20% depending on operational activities) domestic and/or international.
• Bachelor’s Degree (minimum) in medicine or general science.
• Proficient in QA procedures and a thorough knowledge of relevant GCP standards.
• Proven experience (min. 5 years) in Clinical Quality Assurance auditing.
• Ability to review and evaluate clinical data / records.
• Experience of leading CAPA initiatives
• Ability to successfully implement quality plans for all types of systems/processes.
• Ability to liaise successfully with departmental and office management.
• Demonstrated coaching/mentoring skills.
• Good problem resolution skills.
• Good planning and organizational skills with the ability to multi-task and prioritize effectively.
• Competent computer skills including experience with EDMS and computerized audit management systems.
• Strong QMS experience
If you would like further Information you can contact the recruiter directly:
Karen Shiel | Tel: +353 (0) 1 5079256