Quality Manager

🔥 26 minutes ago

🇷🇸 Serbia – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

👔 Manager

Where this job comes from

Posted on Thermo Fisher Scientific's careers page, not through a job board

First seen by Remote Rocketship 26 minutes ago

Logo of Thermo Fisher Scientific

Thermo Fisher Scientific

10,000+ employees

🧬 Biotechnology

💊 Pharmaceuticals

🏥 Healthcare

Biotechnology • Pharmaceuticals • Healthcare

Thermo Fisher Scientific is the world leader in serving science, with a stated mission to enable customers to make the world healthier, cleaner and safer. The company provides a broad portfolio of laboratory instruments, analytical technologies, diagnostics, consumables, software and services that support life‑sciences research, analytical testing, clinical diagnostics and the development and manufacture of therapies. Its operations and offerings (as described on its site and in its news) include advanced imaging and electron microscopes, chromatography and mass‑spectrometry systems, genetic and clinical testing, lab automation and AI tools, bioprocessing and contract development/manufacturing services (brands cited include Thermo Scientific, Applied Biosystems, Invitrogen, Gibco, Fisher Scientific, Unity Lab Services, Patheon and PPD). Thermo Fisher reports annual revenue over $45 billion and emphasizes corporate social responsibility, environmental and community programs alongside its scientific products and services.

📋 Description

• 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

🎯 Requirements

• 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

🏖️ Benefits

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

Apply Now

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