Supplier Quality Expert
This role is a pivotal position within the organization, focusing on supplier quality processes and oversight.
* Manage change control and perform impact assessments to ensure seamless supplier management.
* Own supplier-related deviations and SCARs, driving investigations and root cause analysis.
* Support the quality agreement lifecycle from initiation to coordination, maintaining strong relationships with suppliers.
* Collaborate with QA Auditors in internal/supplier audits and contribute to inspection readiness initiatives.
* Conduct supplier qualification/re-evaluation, risk and quality assessments to inform strategic decisions.
* Develop and revise departmental procedures to optimize supplier management.
* Compile data for Annual Product Quality Review (APQR) reports.
* Lead supplier site visits for investigations and employee training initiatives.
* Support external audits/inspections and handle post-inspection follow-ups and documentation.
* Perform other duties as assigned to drive business growth and excellence.
Key Qualifications
* Strong understanding of GMP/cGMP and international regulations to ensure compliance.
* Experience with supplier quality, deviation handling, and change control to drive process improvements.
* Excellent technical writing, communication, collaboration, and training skills to engage stakeholders.
* Ability to work independently and prioritize deadlines to meet business objectives.
* Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, etc.) to streamline tasks and workflows.