Quality Manager

🔥 7 minutes ago

🌐 Serbia, Greece, +5 more countries – Remote

🇷🇸 Serbia – Remote 🇬🇷 Greece – Remote 🇧🇬 Bulgaria – Remote 🇭🇺 Hungary – Remote 🇵🇹 Portugal – Remote 🇪🇸 Spain – Remote 🇭🇷 Croatia – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

👔 Manager

👻 Ghost score 10%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1956

🏥 Healthcare

📦 Logistics

🏭 Manufacturing

Healthcare • Logistics • Manufacturing

Thermo Fisher Scientific is the world leader in serving science, with annual revenue of more than $40 billion. Their mission is to enable customers to make the world healthier, cleaner, and safer by supporting life sciences research, solving complex analytical challenges, increasing laboratory productivity, and improving patient health through diagnostics and the development of life-changing therapies. With a global team, they offer innovative technologies and pharmaceutical services through brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.

📋 Description

• 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

🎯 Requirements

• 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

🏖️ Benefits

• Fully remote work arrangement