Global Patient Safety Business Excellence, Senior Manager
Listed on 2026-10-12
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Business
Regulatory Compliance Specialist, Change Management, Operations Management
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. Our shared mission—to serve patients living with serious illnesses—drives all that we do. 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. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based.
If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
What you will do Let’s do this. Let’s change the world.
ResponsibilitiesLead 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.
We are all different, yet we all use our unique contributions to serve patients. The safety business excellence professional we seek has these qualifications.
Basic QualificationsBasic Qualifications:
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
Preferred Qualifications:
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…
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