Amgen Inc
Global Patient Safety Business Excellence, Senior Manager
United States - Remote · Senior
Sponsorship not specifiedDetected 1 day ago
Project ManagementLogisticsProcess ImprovementFDA RegulatoryPharmacovigilanceResearchLeadershipCritical ThinkingMentoringPublic SpeakingRegulatory Affairs
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16Unrated
Cap-exempt (no lottery)0
Sponsors this role0
Entry-level history0
PERM / green-card track0
Lottery odds40
Fits your clock70
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About the role
- Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases.
- With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year.
- Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions.
Responsibilities
- 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.
- Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness
- Develop, monitor, and report key performance and compliance metrics to support management review, strategic decision-making, and continuous improvement.
- Build and maintain strong partnerships with internal and external stakeholders, influencing decisions and driving alignment across complex organizational initiatives.
- In this vital role, you will drive business excellence initiatives across Global Patient Safety (GPS), providing leadership in project management, organizational change management, governance, compliance oversight, and operational effectiveness.
- You will 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.
Requirements
- Doctorate degree & 2 years of Safety Project Management experience
- Master's degree & 4 years of Safety Project Management experience
- Bachelor's degree & 6 years of Safety Project Management experience
- Associate's degree & 10 years of Safety Project Management experience
- High school diploma / GED & 12 years of Safety Project Management experience
- Able to comprehend pharmacovigilance regulations, compliance practices and ability to interpret multiple requirements into concise clear instructions.
Nice to have
- Demonstrated expertise in project management, change management, and organizational transformation.
- Strong leadership acumen and the ability to influence without authority
- 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
- 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
Compensation
- 140,799.10USD -190,492.90 USD
Benefits
- Support Health Authority Inspection, Business Partner audits and Internal Process Audits within the remit of role and responsibility, including logistics and operational support
Company info
- Career Category Safety Job Description Join Amgen's Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are.
- If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team.
- What we expect of you We are all different, yet we all use our unique contributions to serve patients.
- We are all different, yet we all use our unique contributions to serve patients. The safety business excellence professional we seek has these qualifications.
- We are all different, yet we all use our unique contributions to serve patients.
Equal opportunity
- Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
- Please contact us to request accommodation.
- We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.
Visa & Work Authorization
- Sponsorship for this role is not guaranteed.
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