Senior Quality Officer (QEs and CAPAs) - Remote

Overview

The Senior Quality Management Officer is responsible for ensuring that Quality Events (QEs) and Corrective and Preventative Actions (CAPAs) are completed in an accurate and timely fashion and are managed in compliance with global regulations, legislation, and PrimeVigilance requirements.

In Short

• Lead the administration, tracking, and management of QEs and CAPAs at PrimeVigilance.
• Co-ordinate root cause investigation meetings and support Subject Matter Experts to conduct efficient root cause analysis.
• Lead QEs and CAPAs management through the workflow.
• Provide support to operations and act as subject matter expert on process of managing QEs and CAPAs.
• Participate and lead in business process optimization and continuous improvement projects/activities.
• Exercise oversight over timely completion of action items for QEs raised for US projects.
• Participate in audits and inspections as a QE and CAPA subject matter expert.
• Provide training and coaching to junior QE and CAPA team members.
• Support the line manager for periodic trending of deviations data across the company.
• Provide peer review of QE work performed by colleagues.

Requirements

• University degree in Biomedical sciences, Natural sciences or Health Sciences.
• Relevant experience in a Quality and/or Compliance-related role.
• Prior experience in Pharmacovigilance, Medical Information, or Medical Devices.
• Experience of using an electronic Quality Management System desirable but not required.

Benefits

• Training and career development opportunities internally.
• Strong emphasis on personal and professional growth.
• Friendly, supportive working environment.
• Opportunity to work with colleagues based all over the world.