P95
51 - 200 employees
💊 Pharmaceuticals
⚕️ Healthcare Insurance
🔬 Science
Pharmaceuticals • Healthcare Insurance • Science
P95 is a full-service Contract Research Organization (CRO) specializing in vaccine development and infectious diseases. With over 25 years of experience and a presence spanning five continents, P95 offers comprehensive clinical trial solutions from early to late phases. The company excels in epidemiology and real-world evidence with a strong focus on vaccines, infectious diseases, and emerging markets like Africa and LMICs. P95's services include clinical trial delivery, data management, biostatistics, safety management, and medical writing, aiming to advance vaccine development and positively impact global health.
Senior Manager, Quality
🕒 May 8
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P95
51 - 200 employees
💊 Pharmaceuticals
⚕️ Healthcare Insurance
🔬 Science
Pharmaceuticals • Healthcare Insurance • Science
P95 is a full-service Contract Research Organization (CRO) specializing in vaccine development and infectious diseases. With over 25 years of experience and a presence spanning five continents, P95 offers comprehensive clinical trial solutions from early to late phases. The company excels in epidemiology and real-world evidence with a strong focus on vaccines, infectious diseases, and emerging markets like Africa and LMICs. P95's services include clinical trial delivery, data management, biostatistics, safety management, and medical writing, aiming to advance vaccine development and positively impact global health.
📋 Description
• Oversees and leads the end-to-end execution and continuous improvement of core QMS processes • Ensures these processes are applied consistently across teams, functions, and projects • Defines, implements, and monitors key quality metrics related to deviations, CAPA effectiveness, risk trends, and change management • Acts as line manager for Quality Managers, providing clear direction, coaching, and performance management • Ensures consistent and high-quality operational management of deviations, CAPA, risk management, and change control processes
🎯 Requirements
• Bachelor’s or advanced degree in Life Sciences or a related field • Extensive experience in a GxP-regulated environment • Strong expertise in GxP principles (GCP, GVP, GEP, etc.) and regulatory frameworks • Proven experience in managing deviation/non-compliance, CAPA, risk management, and change control processes • Extensive experience in hosting client audits and supporting regulatory inspections, as well as conducting internal and vendor audits • Strong ability to analyse quality metrics, identify trends, and drive continuous improvement initiatives
🏖️ Benefits
• Health insurance • Remote work flexibility • Opportunities for research and development
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