Global Patient Safety Business Excellence, Senior Manager
Amgen
Summary
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.
Job description
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.
- 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.
Basic 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 OR
- High school diploma / GED & 12 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 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.
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 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
- Retirement and Savings Plan
- Medical, Dental & Vision
- Life and Disability Insurance
- Flexible Spending Accounts
- Discretionary Annual Bonus
- Stock-based Long-term Incentives
- Award-winning Time-off Plans
- Flexible Work Models
Company overview
Amgen Inc. is a leading American multinational biopharmaceutical company headquartered in Thousand Oaks, California, founded in 1980. As one of the world's largest independent biotechnology companies, Amgen specializes in discovering, developing, manufacturing, and delivering innovative human therapeutics. The company focuses on six key therapeutic areas: inflammation, oncology/hematology, bone health, cardiovascular disease, nephrology, and neuroscience. Amgen's portfolio includes blockbuster drugs such as Enbrel for autoimmune diseases, Prolia and XGEVA for osteoporosis, Repatha for cholesterol management, Otezla for psoriasis, and Neulasta for chemotherapy-induced neutropenia. With approximately 28,000 employees worldwide, Amgen operates as a component of both the Dow Jones Industrial Average and Nasdaq-100 indices. The company maintains a robust research and development pipeline with numerous clinical programs across various stages, leveraging cutting-edge biotechnology and human genetic data to address some of the world's most challenging diseases. Amgen's manufacturing capabilities span multiple global locations, and it distributes products through pharmaceutical wholesale distributors and direct-to-consumer channels.