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Senior Supplier Quality Engineer

Job in Warsaw, Kosciusko County, Indiana, 46580, USA
Listing for: Katalyst CRO
Full Time position
Listed on 2026-02-09
Job specializations:
  • Quality Assurance - QA/QC
    Quality Engineering
  • Engineering
    Quality Engineering, Process Engineer
Job Description & How to Apply Below

Overview

We are seeking an experienced Senior Supplier Quality Engineer to lead supplier quality assurance activities for external manufacturing partners within a pharmaceutical / regulated environment.

Responsibilities
  • Lead supplier quality assurance for externally manufactured pharma products
  • Own supplier approval & qualification, including audits and quality system assessments
  • Drive supplier development to improve process capability, compliance, and inspection readiness
  • Manage supplier change control (process changes, transfers, equivalency, obsolescence)
  • Plan and execute supplier process validations aligned with GMP & ISO standards
  • Identify and mitigate supplier quality and supply risks proactively
  • Collaborate cross-functionally with Sourcing, R&D, Manufacturing, Quality, and suppliers
Education & Experience
  • Strong Supplier Quality Engineering experience in pharma or regulated industries
  • Solid knowledge of GMP, ISO, and regulatory expectations
  • Hands-on experience with audits, validation, and change management
  • Excellent communication, project management, and stakeholder engagement skills
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Position Requirements
10+ Years work experience
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