Senior Quality Assurance Manager

Role Overview

• Ensures continuous quality improvement through effective management and oversight of Audits and Inspections
• Facilitates ongoing quality improvement measures through communication of audit & Inspection intelligence and compliance guidance/training
• Leads, educates, mentors, and develops the team within the function to ensure their competence and confidence in developing to become subject matter experts
• Ensures that reporting, review and analysis of Findings from Audits and Inspection and CAPAs is performed efficiently and in compliance with global regulations, legislation and PrimeVigilance requirements
• Manages and maintains the electronic quality management system (EG-QMS) Audits module -CAPA Management
• Performs periodic trending of Findings across the company, providing insights into the potential causes of trends to operational and quality management
• Fosters a culture of quality within the organisation as led by members of the Quality Leadership Team
• Participates in audits and inspections, including document request provision, front and back-room activities, and follow-up of audit and inspection findings and completion of client questionnaires and RFP/RFI
• Acts as a Subject Matter Expert and client point-of-contact for Quality including attendance at operational and quality governance meetings
• Collaborates and guides operational personnel to ensure effective root cause analysis and writing/delivery of appropriate CAPA Plans and develops and delivers training on these topics and other quality topics
• Generates metrics on CAPA compliance
• Assists in the development, maintenance and management of mechanisms that assure ongoing monitoring and compliance with all applicable laws and regulations including but not limited to EU GVP, US FDA CFRs, JMPA and ICH-E6
• Procedural creation, management revision

Requirements

• A university degree in a healthcare discipline or equivalent scientific area
• Substantial experience in pharmaceutical/biotechnology pharmacovigilance with a in depth understanding of GVP/GCP-related Quality Management and Assurance
• Sound knowledge of international regulations related to Pharmacovigilance and Medical Information
• Experience of participating in audits and inspections
• Ability to lead, mentor, and develop teams
• Excellent communication and facilitation skills within a global organization
• Proactive and self-motivated with strong organizational and planning abilities
• Excellent problem-solving and decision-making skills
• Attention to detail and commitment to high standards
• Ability to analyze data and prepare detailed reports
• Knowledge of quality management principles and practices

Tech Stack

• Google Cloud Platform

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, with English as the company language