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Senior Supplier Quality Engineer
Job in
Warsaw, Kosciusko County, Indiana, 46580, USA
Listed on 2026-02-09
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
- 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
Position Requirements
10+ Years
work experience
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