
Senior Supplier Quality Manager
5 days ago
This is a senior quality assurance position responsible for managing and maintaining relationships with suppliers to ensure they meet our company's standards.
The primary objective of this role is to perform quality activities such as supplier qualification, periodic performance monitoring, supplier change notification, and decommissioning. This involves working closely with stakeholders and suppliers to ensure relevant documents are completed, leading on-site audits at supplier sites, preparing audit agendas and reports, and coordinating corrective actions.
- Key Responsibilities:
- Liaise with affiliate site personnel for qualified supplier information decks.
- Draft or review Quality Agreements (QAA) with new or existing suppliers.
- Perform quality assessments based on company procedures to determine if suppliers can be qualified for use.
- Update qualified supplier lists.
- Perform periodic performance monitoring, supplier change notifications, and decommissioning of suppliers.
About You
- A bachelor's degree or higher in a relevant field such as Biologics, Pharmacy, Pharmaceutical Engineering, Bioengineering, or related fields is required.
- At least 8 years of working experience in production and/or quality management, with a minimum of 5 years in supplier qualification QA is required.
- Familiarity with FDA, EMEA, HSA, and PIC/S GMP requirements is necessary.
- Experience leading audits is preferred.
- Proficient in English listening, speaking, reading, and writing is required.
- Skilled in Microsoft Office, SAP, and other relevant tools is necessary.
- Strong learning ability and effective cross-functional communication and collaboration skills are essential.
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