Senior Manager, Global Patient Safety Business Excellence

Amgen

Senior Manager driving business excellence initiatives in Global Patient Safety for biotech company Amgen. Collaborating across teams to ensure project success and operational integrity with regulatory compliance.

Posted 7/30/2026full-timeRemote • 🇺🇸 United StatesSenior💰 $140,799 - $190,492 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Project Management and Change Management within Global Patient Safety, ensuring compliance with pharmacovigilance regulations and driving operational effectiveness through digital transformation and data-driven insights.

Highest-signal resume keywords

Project ManagementChange ManagementPharmacovigilance RegulationsPMP CertificationGovernance Frameworks

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Safety Project ManagementOperational EffectivenessQuality Management SystemProcess ImprovementData AnalysisLean MethodologySix SigmaAgile MethodologyCompliance OversightInspection Readiness

Soft Skills

Leadership AcumenInterpersonal SkillsCritical ThinkingDecision-MakingFacilitation Skills

Tools & Technologies

Digital TechnologiesAutomationAnalytics

Certifications & Qualifications

PMP Certification

Industry Keywords

Global Patient SafetyPharmacovigilanceRegulatory AffairsLife SciencesMergers and Acquisitions

Tech Stack

Tools & technologies

PMP

About the role

Key responsibilities & impact

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.

Requirements

What you’ll need

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.

Benefits

Comp & perks

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.