Career CategoryRegulatory
Job DescriptionR&D Supplier Governance Manager What you will doLet's do this. Let's change the world. In this vital role you will support Amgen sponsored clinical trials globally, reporting to the Sr. Manager of R&D Supplier Governance, you will ensure appropriate governance and oversight of equipment and ancillary suppliers, support programs and study teams, collaborate with senior management, and partner with internal stakeholders and suppliers for process improvement. We support our clinical trials around the world. Come join an outstanding team that delivers for our study teams and our patients! Potentially up to 20% travel domestic and/or international.
Key Activities and responsibilities include:
- Focus on Equipment and Ancillary suppliers with some overlap into customs and logistics
- Ensure quality oversight of suppliers through:
- Working with suppliers and internal customers (typically up to Director level) to identify, lead, raise and resolve issues related to supplier performance
- Measuring supplier performance and reporting performance feedback to internal partners and suppliers
- Financial oversight of suppliers across portfolio of work
- Facilitating and implementing supplier governance meetings, operating reviews, monitoring key performance indicators, risk management and mitigation and performing issue management
- 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
What we expect of youWe are all different, yet we all use our unique contributions to serve patients. The experienced professional we seek is a unique leader with these qualifications.
Basic Qualifications: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
Preferred Qualifications:- BA/BS/BSc in the sciences or RN
- 7 years 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).
- Experience at, or oversight of, clinical research suppliers (equipment, medical devices, and/or ancillary supplies, etc.)
- 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
- Experience working in a global, matrix organization.
- 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.
What you can expect of usAs 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.
Apply now and make a lasting impact with the Amgen team.careers.amgen.comIn 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 deadlineAmgen 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.
SponsorshipSponsorship for this role is not guaranteed.
Salary Range100,564.35USD -136,057.65 USD
