R&D Supplier Governance Manager (US-Remote)

About the role

Join Amgen’s mission of serving patients. This role supports Amgen-sponsored clinical trials globally, focusing on equipment and ancillary suppliers, and collaborating with senior management and internal stakeholders.

Responsibilities

• Ensure quality oversight of suppliers through identifying, leading, raising, and resolving issues related to supplier performance.
• Measure supplier performance and provide feedback to internal partners and suppliers.
• Facilitate and implement supplier governance meetings, operating reviews, monitor key performance indicators, manage risks, and mitigate issues.
• Build and maintain relationships with key internal and external partners, including study teams, functional leads, procurement, quality, compliance, and suppliers.
• Support business functions with supplier evaluation, selection, and startup of study activities.
• Perform supplier sourcing activities.

Requirements

• Doctorate degree OR Master’s degree and 2 years of relevant experience OR Bachelor’s degree and 4 years of relevant experience OR Associate’s degree and 8 years of relevant experience OR High school diploma / GED and 10 years of relevant experience.
• Bachelor’s degree in the sciences or RN with 4 years of biopharmaceutical clinical trial experience (clinical research experience obtained working on clinical trials at a biotech, pharmaceutical, or CRO company).
• Experience with CE marking, 510(k) clearance, and other device regulation requirements.
• Experience with customs (import/export) and logistics.
• Ability to keep the “big picture” in mind while dealing with the details, to envision and implement business process solutions, prioritize competing objectives, working under multiple and competing deadlines.
• Knowledge of Good Clinical Practices (GCP), FDA regulations and guidelines, and international regulatory requirements/guidelines.
• Project management/project planning experience.
• Proficiency in anticipating and resolving problems.
• Experience writing and communicating clearly on scientific and clinical issues.
• Excellent interpersonal, organizational, supervisory skills.
• Professional collaboration and leadership skills.

Qualifications

• BA/BS/BSc in the sciences or RN with 7 years of work experience in life sciences or medically related field, including 4 years of biopharmaceutical clinical trial experience (clinical research experience obtained working on clinical trials at a biotech, pharmaceutical, or CRO company).

Skills

• Experience with CE marking, 510(k) clearance, and other device regulation requirements.
• Experience with customs (import/export) and logistics.
• Ability to keep the “big picture” in mind while dealing with the details, to envision and implement business process solutions, prioritize competing objectives, working under multiple and competing deadlines.
• Knowledge of Good Clinical Practices (GCP), FDA regulations and guidelines, and international regulatory requirements/guidelines.
• Project management/project planning experience.
• Proficiency in anticipating and resolving problems.
• Experience writing and communicating clearly on scientific and clinical issues.
• Excellent interpersonal, organizational, supervisory skills.
• Professional collaboration and leadership skills.

Benefits

Refer to the Work Location Type in the job posting to see if this applies. Amgen offers 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. There is a discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan. Stock-based long-term incentives are also available. Award-winning time-off plans, flexible work models where possible, and more are included in the Total Rewards Plan.

Pay

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.

Schedule

There is a potential for up to 20% travel domestic and/or international.