R&D Supplier Quality Manager
R&D Supplier Quality Manager
United States - Remote APLICAR AHORAJoin 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. 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.
R&D Supplier Quality Manager
What you will do
Let’s do this. Let’s change the world. R&D Quality is developing a Supplier Quality Oversight capability with the primary objective of delivering a robust, risk-based supplier quality program capable of identifying key leading indicators which will predict and prevent critical quality issues.
This role as R&D Supplier Quality Manager will report to the Director or Sr. Manager, R&D Supplier Quality Management in Precision Medicine, Diagnostics and Supplier Quality (PMDSQ) and will be responsible for the operational execution of supplier quality management processes for R&D suppliers operating under GCP, GLP, and GPvP regulatory frameworks. This tactical role will focus on hands-on quality oversight of third-party suppliers to ensure compliance, mitigate risks, and promote continuous improvement across the supplier lifecycle—from onboarding to issue management and offboarding.
This position plays a critical role in implementing the R&D Supplier Quality Management program, ensuring alignment with Amgen’s internal quality standards, procedures, and regulatory obligations. The ideal candidate is diligent, action-driven, and adept at performing cross-functional quality processes in a matrixed global environment.
Key Areas of Responsibility:
Complete supplier qualification and oversight activities by conducting risk-based assessments, supporting the development, review, and lifecycle management of supplier quality agreements, and ensuring compliance with GCP, GLP, and GPvP regulations.
Monitor and report R&D Supplier Quality performance metrics by tracking KPIs, identifying quality trends to ensure timely and appropriate escalation
Lead supplier audit coordination by organizing supplier audits, capturing findings, initiating quality records, and tracking timely closure of CAPAs.
Manage and maintain supplier quality data in electronic quality systems (e.g., Veeva, TrackWise), ensuring data accuracy, traceability, and audit/inspection readiness.
Foster collaborative partnerships and manage supplier relationships by working with R&D, Supply Chain, Procurement, and Quality Assurance to align on supplier onboarding and operational requirements; engaging with external suppliers and contract organizations under mentorship; and supporting governance and cross-functional initiatives led by senior staff.
Drive compliance to procedures and documentation standards by following SOPs, performing peer quality checks, and supporting continuous improvement initiatives.
Willing and able to travel up to 15%
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek has technological literacy and leadership skills and has these qualifications.
Basic Qualifications:
Doctorate degree OR
Master’s degree and 3 years of relevant experience OR
Bachelor’s degree and 5 years of relevant experience OR
Associate’s degree and 10 years of relevant experience OR
High school diploma / GED and 12 years of relevant experience
In addition to meeting at least one of the above requirements, you must have experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above
Preferred Qualifications:
Experience within the pharmaceutical/biotech or medical device industry working in quality management systems role or other relevant experience in a clinical research environment that includes quality oversight (e.g. deviation management/CAPA, audit conduct, or inspection support).
Supplier quality management experience
Audit and risk management training/certification
Familiarity with GxP and ISO standards applicable to R&D suppliers
Strong project management skills
Experience working in a global, matrixed organization across multiple time zones
Working knowledge of GCP, GLP and GPvP regulations, practices, and trends
Experience and results in the areas of implementing new regulations and standards, gap assessment, QMS processes
Flexibility in work hours being in PST or EST.
What you can expect from 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 $107,900 - $129,382. 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, including remote and hybrid work arrangements, where possible
Apply now and make a lasting impact with the Amgen team.
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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.
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. Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status