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Quality Manager
Thermo Fisher Scientific. Execute the Pharmacovigilance Quality Management System within the Global Patient Safety functional area .
About the role
Key responsibilities & impact- Execute the Pharmacovigilance Quality Management System within the Global Patient Safety functional area
- 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 activities
- Ensure inspection documents are readily retrievable and current
- Coordinate and prepare GPS responses to audit and inspection findings
- Assess issue-management trends and implement action plans to mitigate systemic causes
- Identify deviations and support corrective and preventive action determination
- Guide root-cause analysis and lead corrective or preventive action implementation with the client Quality function
- Develop, maintain, expand and deliver pharmacovigilance training programs
- Support training curriculum monitoring, maintenance, reevaluation and updates
- 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 forums and provide GPS input and review
- Support document control using the Veeva system
- Develop and evaluate KPIs aligned with evolving business needs
- 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
- Report to the Associate Director, GPS Quality Management or above
Requirements
What you’ll need- 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
- 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
Benefits
Comp & perks- Fully remote work arrangement
- Standard Monday–Friday work schedule