Senior Manager, Global Patient Safety, Business Excellence

🕒 Julho 30

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $140.799 - $190.492 / ano

⏰ Tempo Integral

🟠 Sênior

👔 Gerente

🦅 Patrocina Visto H1B

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👻 Score fantasma 45%

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Amgen

SiteLinkedInTodas as Vagas

10.000+ funcionários

Fundada em 1980

🏥 Saúde

🧬 Biotecnologia

💊 Farmacêutico

💰 $28.500.000.000 Post-IPO Debt em 2022-12

Healthcare • Biotechnology • Pharmaceuticals

A Amgen está comprometida a liberar o potencial da biologia para pacientes que sofrem de doenças graves, descobrindo, desenvolvendo, fabricando e fornecendo terapias humanas inovadoras. Esta abordagem começa utilizando ferramentas como genética humana avançada para desvendar as complexidades das doenças e entender os fundamentos da biologia humana.

Descrição

• Lead the development, implementation, and continuous improvement of project management and change management standards, methodologies, and best practices across Global Patient Safety • Drive and sustain GPS governance frameworks, ensuring effective oversight, decision-making, and alignment with organizational objectives • Lead and deliver business-critical initiatives within Global Patient Safety and represent GPS on enterprise-wide cross-functional programs • Provide strategic leadership and oversight for pharmacovigilance activities related to mergers, acquisitions, licensing agreements, and divestitures • Contribute to the advancement and effectiveness of the GPS Quality Management System and ensure compliance with global regulatory requirements • Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain inspection readiness • Support Health Authority Inspections, Business Partner audits, and Internal Process Audits, including logistics and operational support • Develop, monitor, and report key performance and compliance metrics for management review, strategic decision-making, and continuous improvement • Facilitate cross-functional management of deviations, CAPAs, and quality improvement initiatives • Build and maintain partnerships with internal and external stakeholders, influencing decisions and driving alignment • Champion digital transformation opportunities, including automation, analytics, and emerging technologies, to enhance Global Patient Safety

🎯 Requisitos

• Doctorate degree & 2 years of Safety Project Management experience OR Master’s degree & 4 years of Safety Project Management experience OR Bachelor’s degree & 6 years of Safety Project Management experience OR Associate’s degree & 10 years of Safety Project Management experience OR High school diploma / GED & 12 years of Safety Project Management experience • Demonstrated expertise in project management, change management, and organizational transformation • Strong leadership acumen and ability to influence without authority • Ability to comprehend pharmacovigilance regulations and compliance practices and interpret multiple requirements into concise, clear instructions • Experience working in an international environment and with cross-functional teams • Critical thinking and decision-making skills; comfort with ambiguity and ability to work independently • Ability to manage time, priorities, and multiple priorities simultaneously • Ability to leverage digital technologies, automation, and data-driven insights • Strength in facilitation, both virtual and in person, including with executive leadership • PMP certification or equivalent in Change or Project Management • Successful execution of major projects in regulatory or safety environments • Experience with mergers, acquisitions, and divestitures in Life Sciences • Strong leadership experience, ideally with fully remote teams across time zones • Significant experience within pharmacovigilance, drug safety, regulatory affairs, quality, or related life sciences functions • Experience establishing governance frameworks and leading complex, enterprise-wide initiatives • Experience presenting to and influencing senior leadership and executive stakeholders • Strong analytical skills and ability to translate data into actionable business recommendations • Experience leading process improvement initiatives using Lean, Six Sigma, Agile, or similar methodologies

🏖️ Benefícios

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions • Group medical, dental and vision coverage • Life and disability insurance • Flexible spending accounts • A discretionary annual bonus program • Stock-based long-term incentives • Award-winning time-off plans • Flexible work models where possible • Career development opportunities • Financial plans with opportunities to save towards retirement or other goals • Work/life balance support