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Job Description:
In this vital role you will serve as the quality lead and subject matter expert for critical global suppliers of GMP raw materials, specifically Single Use, Resins, and Filters (SURF). You will own the end-to-end quality oversight of assigned suppliers—from onboarding through ongoing performance monitoring to disengagement—ensuring compliance, reliability, and continuous improvement. You will also act as the primary quality contact for internal stakeholders, supporting issue resolution, supplier strategy, and cross-functional initiatives. This role offers a unique chance to make a global impact while developing deep expertise in SURF materials and external quality systems.
Job Responsibility:
- Act as the quality lead for supplier relationships, from onboarding through disengagement, ensuring performance through robust proactive monitoring, technical site visits, and continuous improvement
- Perform proactive quality management of suppliers, ensuring compliance with global regulatory standards, including but not limited to GDP, GMP, ISO, etc and Amgen’s industry leading expectations
- Review and approve quality documentation, including Quality Agreements, deviations, supplier investigations, CAPAs, CAPA EVs, supplier change notifications and change controls, with a sharp eye for risk and compliance
- Participate in and/or lead supplier audits and collaborate with internal and external partners to implement corrective and preventive actions
- Prepare Amgen sites and suppliers for audits and inspections including development of inspection playbooks
- Represent Amgen/ESQ during such audits and inspections – owning our quality story with confidence and clarity
- Identify and mitigate risks at the supplier and/or escalate to management
- Perform Person in Plant activities, as deemed appropriate
- Drive audit commitments to completion
- Act as a key quality partner to External Supply, Manufacturing, Supply Chain, Material Sciences, Engineering Technical Authority (ETA), Process Development and other internal functions
- Take the lead and/or participate in cross-functional initiatives and continuous improvement projects, shaping the future of supplier quality at Amgen
- Roles require 20% travel, both domestic and international travel
Requirements:
- High school diploma / GED and 12 years of Quality experience OR Associate’s degree and 10 years of Quality experience OR Bachelor’s degree and 8 years of Quality experience OR Master’s degree and 6 years of Quality experience OR Doctorate degree and 2 years of Quality experience
- In addition to meeting at least one of the above requirements, you must have a minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources
- Educational background in Life Sciences
- Strong technical knowledge and experience within operations in the pharmaceutical or GMP-regulated industry
- Relevant work experience within Drug Substance and Drug Product operations, ideally with single use systems and platforms
- 5+ years of experience overseeing quality of suppliers
- Robust problem-solving and root-cause analysis experience
- Strong continuous improvement mentality
- Strong compliance, quality, and regulatory knowledge with critical thinking, inquisitive with an end-to-end mentality
- Strong communication skills with proficiency in the English language and collaborative cross-functionally behavior
- Strong report writing and presentation skills
- Experience driving decision-making by using DAI principles
- Understanding of industry requirements/expectations of a QMS
- Savvy with data and Artificial Intelligence tools
- Understanding of the applicable manufacturing/testing processes (i.e. API, Drug Substance, Drug Product, Packaging, Device manufacturing processes)
Nice to have:
- Educational background in Life Sciences
- Strong technical knowledge and experience within operations in the pharmaceutical or GMP-regulated industry
- Relevant work experience within Drug Substance and Drug Product operations, ideally with single use systems and platforms
- 5+ years of experience overseeing quality of suppliers
- Robust problem-solving and root-cause analysis experience
- Strong continuous improvement mentality
- Strong compliance, quality, and regulatory knowledge with critical thinking, inquisitive with an end-to-end mentality
- Strong communication skills with proficiency in the English language and collaborative cross-functionally behavior
- Strong report writing and presentation skills
- Experience driving decision-making by using DAI principles
- Understanding of industry requirements/expectations of a QMS
- Savvy with data and Artificial Intelligence tools
- Understanding of the applicable manufacturing/testing processes (i.e. API, Drug Substance, Drug Product, Packaging, Device manufacturing processes)
What we offer:
- 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
