Supplier Quality Management Director

Job Summary

Supporting the Quality Assurance organization, the part-time remote Supplier Quality Management Director will manage the qualification, oversight, and ongoing management of GxP service providers and suppliers while collaborating cross-functionally to maintain a compliant supplier management program.

Key Responsibilities:

• Lead and support qualification activities for new and existing GxP suppliers and service providers
• Draft, review, negotiate, and maintain Quality Technical Agreements (QTAs) and other supplier quality documents
• Collaborate with cross-functional teams to support business objectives and implement process improvements within the Supplier Quality Management program

Required Qualifications:

• Minimum 5-8 years of experience in Quality Assurance within the pharmaceutical or biotechnology industry
• Demonstrated experience in supplier qualification, auditing, and quality agreement management
• Working knowledge of FDA, EU GMP, ICH, and GxP regulations
• Lead Auditor certification or equivalent supplier auditing experience
• Experience with electronic Quality Management Systems (eQMS) and supplier management platforms