Senior Specialist, Supplier Quality

Role: Senior Supplier Quality Specialist responsible for managing the lifecycle of Quality Technical Agreements (QTAs), executing GMP supplier audits, and supporting overall supplier quality programs in a biopharmaceutical context. Responsibilities include drafting, reviewing, and negotiating QTAs; conducting GMP audits of suppliers, contract manufacturers, and service providers; evaluating corrective actions; supporting supplier qualification and risk assessments; and maintaining regulatory documentation and supplier scorecards. Requirements: Bachelor's degree in Chemistry, Engineering, Life Sciences, or related field; 10-12 years of QA/Supplier Quality experience in biotech/pharma, including direct GMP audit and QTA management; thorough knowledge of global cGMPs, ISO 13485, and regulatory standards. Preferred: ASQ CQA certification; experience supporting health authority inspections; strong negotiation and cross-functional collaboration skills; proficiency in data analytics. High-Value: Focus on supplier quality in biopharma manufacturing, supporting cGMP compliance, audit leadership, and regulatory readiness. Work setup: Fully remote with occasional domestic/international travel up to 30%.