QA Operations Lead – Incoming Materials & Disposition

Regulatory Jobs

West Greenwich (RI)

On-site

USD 118,000 - 160,000

Full time

12 days ago

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Job summary

Amgen is looking for a Manager QA to lead Quality Assurance teams covering Incoming Quality, Raw Material and Product Disposition, with oversight of warehouse QA. The role focuses on timely, compliant material disposition and cross-functional collaboration across site and network teams to improve processes and product quality.

Qualifications include extensive QA leadership with formal degrees (up to Doctorate) and hands-on experience in cGMP, deviations, CAPAs, and change controls.

Qualifications

  • 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 5 years of Quality experience OR
  • Master’s degree and 3 years of Quality experience OR
  • Doctorate degree
  • In addition to meeting at least one requirement, you must have experience directly managing people and/or leadership experience leading teams, projects, programs, or directing resources

Responsibilities

  • Lead QA teams for Incoming Quality, Raw Material, Product Disposition, and warehouse QA.
  • Oversee incoming material inspection, sampling, testing, documentation review, disposition.
  • Ensure timely, risk-based disposition decisions and proper documentation.
  • Monitor metrics across Incoming Quality and disposition to drive improvements.
  • Provide QA guidance for deviations and change controls.
  • Represent QA on site and network teams for process direction and improvement.

Skills

People leadership
Quality systems
Cross-functional collaboration
cgmp knowledge
Risk assessment

Education

High school diploma / GED
Associate’s degree
Bachelor’s degree
Master’s degree
Doctorate degree

Tools

Trackwise
SAP
Veeva

Job description

Amgen is looking for a Manager QA to lead Quality Assurance teams covering Incoming Quality, Raw Material and Product Disposition, with oversight of warehouse QA. The role focuses on timely, compliant material disposition and cross-functional collaboration across site and network teams to improve processes and product quality.

Qualifications include extensive QA leadership with formal degrees (up to Doctorate) and hands-on experience in cGMP, deviations, CAPAs, and change controls.

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