Quality Manager

• Execute the Pharmacovigilance Quality Management System consistently, effectively and efficiently within Global Patient Safety
• Contribute to the growth of the GPS Quality Management function
• Maintain and execute the Comprehensive Training Program
• Manage GPS procedural document activities
• Participate in GPS audit and inspection readiness, support and management
• Contribute to continuous improvement through issue management, process improvement and KPI development
• Support and/or manage GVP audits and inspections
• Support the internal global GVP audit program and inspection readiness in collaboration with the client Quality function
• Prepare GPS team members for inspection readiness activities
• Ensure inspection documents are readily retrievable
• Support coordination and preparation of GPS responses to audit and inspection findings
• Assess GPS issue-management trends and implement action plans to mitigate systemic causes
• Identify internal deviations and support or advise the GPS team on corrective and preventive actions
• Guide root-cause analysis to prevent recurrence
• Lead corrective and preventive action implementation with the client Quality function
• Develop, maintain, expand and deliver pharmacovigilance training
• Monitor, maintain, reevaluate and update GPS training curricula
• Provide training to relevant client employees and third parties when applicable
• Contribute to, develop, review and continuously improve GPS processes and procedures
• Participate in cross-functional procedural-document forums and provide GPS input and review
• Support document control using the Veeva system
• Contribute to and evaluate KPIs as business needs evolve
• Monitor compliance with third-party contractual obligations and pharmacovigilance agreements
• Liaise with QA regarding GPS quality and compliance requirements and deliverables
• Monitor compliance with GPS SOPs and controlled documents
• Perform other tasks assigned by the line manager or GPS leadership

• Excellent planning and organizational skills
• Excellent oral and written communication skills
• Ability to work in a global environment
• Solution-oriented, able to prioritize and work independently
• Robust presentation skills and ability to communicate complex issues clearly
• Demonstrated ability to author and contribute to procedural documents
• Ability to motivate and collaborate with multidisciplinary teams
• Proficiency with Microsoft Office and tracking databases
• Fluency in written and spoken English
• At least a bachelor’s degree in pharmacy, nursing, healthcare, another life-science or technical field, or country-equivalent combination of education and experience
• At least 5 years of experience in the pharmaceutical/biotech industry, including at least 3 years in pharmacovigilance/drug safety
• Track record of operating pharmacovigilance quality systems, processes and teams
• Experience preparing for, hosting and responding to global audits and regulatory inspections
• Working knowledge of pharmacovigilance regulatory requirements and guidance documents, including Europe, the US and Japan
• Knowledge of GxP quality and compliance requirements, processes and measures

• Fully remote work arrangement
• Standard Monday–Friday work schedule