What are the responsibilities and job description for the Senior Supplier Quality Engineer position at Katalyst CRO?
Summary
We are seeking an experienced Senior Supplier Quality Engineer to lead supplier quality assurance activities for external manufacturing partners within a pharmaceutical / regulated environment.
Roles & Responsibilities
We are seeking an experienced Senior Supplier Quality Engineer to lead supplier quality assurance activities for external manufacturing partners within a pharmaceutical / regulated environment.
Roles & 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