Quality Manager

• Execute the Pharmacovigilance Quality Management System within the Global Patient Safety function
• 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 audit and inspection activities
• Prepare GPS team members for inspection readiness and ensure inspection documents are readily retrievable
• Coordinate and prepare GPS responses to audit and inspection findings
• Assess issue-management trends and implement action plans to mitigate systemic causes
• Identify internal deviations and support corrective and preventive actions, including root-cause analysis
• Lead implementation of corrective or preventive actions with the client Quality functional area
• Develop, maintain, expand and deliver pharmacovigilance training programs
• Support monitoring and updating of GPS training curricula
• Provide training to relevant client employees and third parties when applicable
• Develop, review and continuously improve GPS processes and procedures
• Participate in cross-functional procedural-document activities and forums
• Support document control through the Veeva system
• Contribute to development and evaluation of key performance indicators
• Monitor compliance with third-party contractual obligations, PVAs, SDEAs and other agreements
• Liaise with the QA Department regarding GPS quality and compliance requirements and deliverables
• Monitor compliance with GPS SOPs and controlled documents
• Perform other duties assigned by the line manager or GPS Leadership

• At least Bachelor’s degree in pharmacy, nursing, healthcare or 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
• At least 3 years of experience in a relevant pharmacovigilance/drug safety field
• Good track record of operating pharmacovigilance quality systems, processes and teams
• Experience preparing for, hosting and responding to audits and regulatory inspections globally
• Working knowledge of relevant pharmacovigilance regulatory requirements and guidance documents, including Europe, US and Japan
• Knowledge of GXP quality and compliance requirements, processes and measures
• Excellent planning and organizational skills
• Excellent oral and written communication skills
• Ability to work in a global environment
• Solution-oriented, with ability 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

• Fully remote work arrangement