R&D Supplier Quality Manager

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R&D Supplier Quality Manager

LIVE
What you will do

Amgens R&D Quality team is building a robust Supplier Quality Oversight capability to proactively identify and prevent critical quality issues across our supplier network.

As R&D Supplier Quality Manager youll report to the Director or Sr. Manager of Supplier Quality Management within Precision Medicine Diagnostics and Supplier Quality (PMDSQ). Youll be responsible for the operational execution of supplier quality processes for R&D suppliers under GCP GLP and GPvP regulatory frameworks.

This hands-on role involves quality oversight of global and local third-party suppliers ensuring compliance mitigating risks and driving continuous improvement throughout the supplier lifecycle from onboarding to audits issue management and offboarding.

Youll support all categories: GMP clinical GLP pre-clinical and pharmacovigilance working cross-functionally with Supply Chain Procurement QA and external partners.

Key Areas of Responsibility:

• Conducting risk-based supplier assessments managing quality agreements and ensuring regulatory compliance
• Supervising supplier performance via KPIs and quality metrics identifying trends and escalating issues
• Coordinating and executing supplier audits managing findings CAPAs and inspection readiness
• Maintaining supplier data in electronic quality systems (e.g. Veeva TrackWise)
• Supporting training implementation documentation standards and continuous improvement initiatives
• Building collaborative relationships with internal teams and external suppliers
• Willingness to travel up to 15%

WIN
What we expect of you

We value diverse perspectives and outstanding contributions. The ideal candidate is disciplined organized and analytical with strong problem-solving skills and a proactive mindset.

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

Note:. You must also have experience managing people and/or leading teams projects or programs.

Preferred Qualifications:

• Experience in pharma/biotech or medical device industry in a quality management role
• Exposure to clinical research environments with quality oversight responsibilities
• Experience in supplier quality management audits and CAPA processes
• Familiarity with GxP and ISO standards applicable to R&D suppliers
• Strong project management and cross-functional collaboration skills
• Working knowledge of GCP GLP GPvP regulations and trends
• Experience implementing new regulations conducting gap assessments and improving QMS processes

THRIVE
What you can expect of us

As we work to develop treatments that take care of others we also work to care for our teammates professional and personal growth and well-being.

• Vast opportunities to learn develop and move up and across our global organization.
• A diverse and inclusive community of belongings where colleagues are empowered to bring ideas to the table try new things and act.
• Generous Amgen Total Rewards Plan comprising healthcare finance wealth and career benefits.
• Flexible work arrangements.

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Equal opportunity statement

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.
We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process perform essential job functions and receive other benefits and privileges of employment. Please contact us to request accommodation.