Senior Supplier Quality Engineer
Location: Warsaw, IN
Duration: 12+ months
Skills:
We are seeking an experienced Senior Supplier Quality Engineer to lead supplier quality assurance activities for external manufacturing partners within a pharmaceutical / regulated environment.
Key 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
Ideal Profile:
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
Education: At least a bachelor s degree (or equivalent experience) in Computer Science, Software/Electronics Engineering, Information Systems, or a closely related field is required for the project