Senior QA Specialist - Supplier Quality

Role: Senior Specialist, Quality Agreements within Supplier Quality team, responsible for developing, negotiating, and managing Quality Agreements with external suppliers, CMOs, testing labs, and distributors supporting clinical and commercial biopharma programs. Responsibilities: drafting, reviewing, and updating agreements aligned with cGMP, FDA, EMA, ICH standards; serving as primary contact for negotiations; maintaining the master tracker; ensuring integration into overall Supplier Quality Management processes; supporting audits and inspections; driving continuous improvement of agreement templates and workflows. Requirements: Bachelor's in Life Sciences, Chemistry, Pharmacy, Engineering, or related field; minimum 8 years in pharmaceutical/biotech QA; 4+ years in supplier quality; proven experience with Quality Agreement negotiation; strong knowledge of cGMP and global regulatory standards; excellent communication and technical writing skills; proficiency with document management systems. Preferred: direct supplier/vendor management experience, including audits; familiarity with API and excipient supplier quality requirements; strong negotiation skills; capable of working independently in a fast-paced environment. HighValue: experience in supplier quality for biologics or small molecules, supporting clinical and commercial phases, with emphasis on cGMP compliance and regulatory interface. WorkSetup: not specified; location likely hybrid or onsite based on regional operations.