Global Patient Safety Business Excellence, Senior Manager

Regulatory Toolkit; United States; Remote; USD 141.000 - 190.000; Vollzeit

Benefits dieser Stelle

Total rewards plan

Flexible work models

Zusammenfassung

Amgen seeks a Senior Manager, Global Patient Safety Business Excellence, to lead governance, project management, and change initiatives across GPS. You will drive compliance, report metrics, and partner with cross-functional teams to improve operational effectiveness and inspection readiness.

Requirements include advanced degrees and substantial safety project management experience; guide pharmacovigilance activities in mergers, acquisitions, and divestitures, contributing to a data-driven

Qualifikationen

• Doctorate degree or global pharmacovigilance exposure with 2+ years of safety project management experience.
• Master’s degree with 4+ years of safety project management experience qualifies you for the role.
• Bachelor’s degree with 6+ years in safety project management meets requirements.
• Associate’s degree with 10+ years of safety project management experience qualifies.

Aufgaben

• Lead development and improvement of project management and change management standards for GPS.
• Drive GPS governance frameworks and ensure alignment with objectives.
• Deliver cross-functional initiatives and support enterprise programs.
• Provide oversight for pharmacovigilance activities in M&A, licensing, and divestitures.
• Support GPS Quality Management System and regulatory compliance.
• Assist PV activities with PV Master File and inspection readiness.
• Support health authority inspections and internal audits.
• Develop and report KPIs for management review and decision making.
• Facilitate deviations, CAPAs, and quality improvement initiatives.
• Build partnerships with stakeholders and drive alignment across initiatives.
• Champion digital transformation using automation, analytics, and new tech.

Kenntnisse

Safety project management

Leadership

Regulatory/pharmacovigilance know-how

Global/international collaboration

Critical thinking

Time/priority management

Digital transformation

Facilitation

PMP certification

Governance frameworks

Executive stakeholder management

Data analytics

Lean/Six Sigma/Agile

Remote team leadership

Pharmacovigilance exposure

Ausbildung

Doctorate degree

Master’s degree

Bachelor’s degree

Associate’s degree

High school diploma

Jobbeschreibung

Career Category

Safety

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. 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.

Global Patient Safety Business Excellence, Sr Manager

What you will do

Let’s do this. Let’s change the world. 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.

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.

What we expect of you

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 Qualifications:

Doctorate degree & 2 years ofSafety Project Management experience

OR

Master’s degree & 4 years ofSafety Project Management experience

OR

Bachelor’s degree & 6 years ofSafety Project Management experience

OR

Associate’s degree & 10 years ofSafety Project Management experience

OR

High school diploma / GED & 12 years ofSafety 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 certificationor 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.

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

• 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. Refer to the Work Location Type in the job posting to see if this applies.

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

Application deadline

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

Sponsorship

Sponsorship for this role is not guaranteed.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

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.

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. Please contact us to request accommodation.

Salary Range

140,799.10USD -190,492.90USD