BioSpace
R&D Supplier Quality Manager
Join Amgen's mission of serving patients. If you feel like you're part of something bigger, it's because you are. Since 1980, we've helped pioneer biotech in the fight against the world's toughest diseases. With focus on Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. Amgen's award-winning culture is collaborative, innovative, and science-based.
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
Masters degree and 3 years of relevant experience OR
Bachelors degree and 5 years of relevant experience OR
Associates 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 of 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 will 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, comprising 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.
careers.amgen.com
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.
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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
Masters degree and 3 years of relevant experience OR
Bachelors degree and 5 years of relevant experience OR
Associates 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 of 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 will 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, comprising 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.
careers.amgen.com
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.
#J-18808-Ljbffr