Senior Manager, Global Patient Safety, Business Excellence

🕒 July 30

🇺🇸 United States – Remote

💵 $140.8k - $190.5k / year

⏰ Full Time

🟠 Senior

👔 Manager

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Amgen

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1980

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

💰 $28.5G Post-IPO Debt on 2022-12

Healthcare • Biotechnology • Pharmaceuticals

Amgen is a global leader in biotechnology, focusing on the development and commercialization of innovative medicines made from living cells. The company aims to treat serious illnesses, often targeting diseases with limited therapeutic options. Amgen emphasizes scientific innovation and is committed to ethical research, patient safety, and environmental sustainability. It actively engages in clinical trials and is known for its contributions to the fields of cancer treatment and obesity management among others.

📋 Description

• 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

🎯 Requirements

• 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

🏖️ Benefits

• 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

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