- Liverpool, England, United Kingdom
- 3+ years
Responsible for quality oversight of suppliers across the EMEA region, managing supplier qualification, risk management, change control, and issue resolution.
Responsibilities
- Manage supplier qualification, onboarding, periodic review, and ongoing oversight activities in accordance with GxP requirements and company standards.
- Review and assess supplier quality documentation, including change notifications, deviations, investigations, CAPAs, regulatory inspection outcomes, and quality metrics.
- Evaluate supplier changes, quality events, and compliance issues using a risk-based approach to determine potential impact on product quality, patient safety, regulatory compliance, and continuity of supply.
- Partner with suppliers and internal stakeholders to investigate and resolve supplier quality issues in a timely manner.
- Establish, review, and maintain Supplier Quality Agreements with suppliers and service providers.
Requirements
- Bachelor's degree in Science, Engineering, Quality, or a related discipline