Senior Project Manager

🕒 Outubro 1

🇺🇸 Estados Unidos – Remoto (EUA)

⏰ Tempo Integral

🟠 Sênior

👷‍♀️ Gerente de Projetos

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Meridian Bioscience Inc.

SiteLinkedInTodas as Vagas

501 - 1000 funcionários

🏥 Saúde

💼 Consultoria

🍽️ Alimentos e Bebidas

💰 Grant em 2022-01

Healthcare • Consulting • Food & Beverage

Meridian Bioscience Inc. é um fabricante líder de reagentes moleculares e imunológicos projetados para aplicações diagnósticas. A empresa é especializada em fornecer soluções inovadoras para aprimorar os diagnósticos no ponto de atendimento e otimizar o desenvolvimento de ensaios para várias condições médicas, incluindo doenças infecciosas e cânceres. A Meridian é dedicada ao avanço dos diagnósticos médicos e à melhoria dos resultados dos pacientes por meio de seus produtos e serviços de alta qualidade.

Descrição

• Lead complex, cross-functional new product development projects for in vitro diagnostic assays and diagnostic instrument systems • Manage project planning and execution from concept through launch • Define project scope, goals, deliverables, success criteria, and governance • Develop and maintain integrated project plans, timelines, critical paths, dependencies, resource needs, and key decision points • Communicate project plans and changes to team members and leadership • Drive team ownership and commitment to project plans • Identify risks, issues, tradeoffs, and required changes to meet project objectives • Track, analyze, and communicate project performance, including schedule, milestones, risks, resources, and budget • Provide status updates, forecasts, and escalations to leadership • Ensure on-time completion of deliverables in accordance with commitments, design control requirements, and company procedures • Lead and facilitate cross-functional project teams, decision-making, issue resolution, and alignment across functions and external partners • Partner with R&D, Operations, Regulatory Affairs, Quality, Clinical Affairs, Finance, Marketing, and external development partners • Perform other duties as assigned

🎯 Requisitos

• Bachelor’s degree in science, engineering or business administration or related field required • At least 7 years of project management experience leading cross-functional product development projects • Significant experience managing complex, multi-functional projects from concept through launch • Direct experience managing FDA-regulated in vitro diagnostic (IVD) product development projects • Proven track record leading IVD products through FDA clearance or approval and commercial launch in the U.S. market • Strong working knowledge of medical device design control requirements and product development processes • Experience with design planning, design reviews, risk management, verification and validation, transfer, regulatory submission, and launch readiness • Experience with IVD products, including assay and/or diagnostic instrument development • Experience working within Quality Management Systems compliant with FDA 21 CFR Part 820 and applicable medical device regulations • Project management qualification (PMP) or equivalent preferred • Advanced project management skills and practical project management experience, preferably in the diagnostic field • Successful leadership of product development projects with significant technical, regulatory, operational, and/or cross-functional complexity • Capability to perform critical path analysis, dependency management, risk management, and scenario planning • Excellent problem-solving and decision-support skills • Ability to prioritize competing demands, balance workloads and timelines, and work on multiple projects simultaneously • Ability to work independently with limited oversight while influencing and collaborating with peers, functional leaders, senior stakeholders, and external partners • Ability to meet strict deadlines and perform under pressure in a fast-paced work environment • Excellent interpersonal, organizational, written, and oral communication skills • Basic understanding of IVD product development, including assay and/or instrument development, engineering, verification and validation, regulatory, quality, clinical, manufacturing, transfer, and launch activities • Willingness to travel 20%

🏖️ Benefícios

• Travel as required to support project teams and key milestones • Remote work option • Travel allowance implied by required 20% travel