Senior Manager, Global Patient Safety Business Excellence

🕒 Julho 30

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $140.799 - $190.492 / ano

⏰ Tempo Integral

🟠 Sênior

👔 Gerente

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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

• Drive business excellence initiatives across Global Patient Safety (GPS) • Provide leadership in project management, organizational change management, governance, compliance oversight, and operational effectiveness. • Partner across GPS and key cross-functional stakeholders to enable successful delivery of business-critical initiatives, strengthen inspection readiness, and advance a culture of continuous improvement. • Lead the development, implementation, and continuous improvement of project management and change management standards, methodologies, and best practices across GPS. • 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, ensuring compliance with global regulatory requirements. • Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness • Support Health Authority Inspection, Business Partner audits and Internal Process Audits within the remit of role and responsibility, including logistics and operational support • Develop, monitor, and report key performance and compliance metrics to support management review, strategic decision-making, and continuous improvement. • Facilitate cross-functional management of deviations, CAPAs, and quality improvement initiatives to ensure sustainable compliance outcomes. • Build and maintain strong partnerships with internal and external stakeholders, influencing decisions and driving alignment across complex organizational initiatives. • Champion digital transformation opportunities, including the adoption of 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 the ability to influence without authority • Able to comprehend pharmacovigilance regulations, compliance practices and ability to interpret multiple requirements into concise clear instructions. • Proven ability to work in international environment and with cross-functional teams, with good interpersonal skills / assertiveness / team spirit / coaching skills • Critical thinking and decision-making skills; comfort with ambiguity and able to work independently as needed • Able to manage both time and priority constraints and to manage multiple priorities simultaneously • Demonstrated ability to leverage digital technologies, automation, and data-driven insights to improve operational effectiveness and business outcomes. • Strength in facilitation, both virtual and in person (including with executive leadership) • PMP certification or equivalent in Change or Project Management • A history of successful execution of major projects in regulatory or safety environment • Experience of 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. • Proven experience establishing governance frameworks and leading complex, enterprise-wide initiatives. • Experience presenting to and influencing senior leadership and executive stakeholders. • Strong analytical skills with the 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, and flexible spending accounts • A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan • Stock-based long-term incentives • Award-winning time-off plans • Flexible work models where possible.