Sr. Supplier Manager

Job Description | Sr. Supplier Quality Manager Location | Totowa, NJ or Dulles, VA Department | Quality & Compliance Reports To | Director, Quality Management NJ5 Training Curriculum ID | TCU.001 Pay Range: $130,000-140,000/yr Overview SOFIE aseptically manufactures therapeutic and diagnostic radiopharmaceuticals across the US, operating under both 21 CFR Part 212 (diagnostic manufacturing) and 21 CFR Part 211 and EudraLex Volume 4 (therapeutic manufacturing at NJ5, our Therapeutic Center of Excellence). The Sr. Supplier Quality Manager provides strategic leadership and oversight of the company-wide Supplier Quality Program, ensuring robust and compliant processes for vendor qualification, monitoring, and continuous improvement across SOFIE’s diverse network. This role directly manages the Supplier Quality Manager and serves as the primary Quality lead for supplier-related initiatives across both regulatory frameworks. Essential Duties and Responsibilities Leadership & Management • Provide mentorship, coaching, and direct supervision of Supplier Quality Manager(s). • Serve as the primary corporate authority on supplier quality across SOFIE. Program Ownership • Lead the design, governance, and improvement of SOFIE’s Supplier Quality Programs across all 21 CFR 212 sites and NJ5 (21 CFR 211, Eudralex Volume 4, and ROW regulations). • Harmonize supplier qualification, monitoring, and auditing practices across sites while ensuring sitespecific compliance requirements are met. • Develop and maintain policies, SOPs, and standards for supplier quality management. Regulatory & Compliance • Ensure all supplier quality systems are fully compliant with FDA regulations, ICH guidelines, and applicable standards. • Interpret and apply differences between 21 CFR 211 and 212, EU and ROW supplier requirements, tailoring programs accordingly. • Act as SME during regulatory (FDA, EMEA, etc.) and customer inspections related to supplier management. Vendor Qualification & Oversight • Oversee vendor qualification, auditing, and requalification activities. • Ensure approved vendor lists and other tracking tools are maintained and current, that individual vendor qualification documents are complete, correct and current, and that vendors are requalified by due date. • Review and approve Quality Agreements, ensuring alignment across therapeutic and diagnostic programs. Ensure consistency between NDA, master business agreements and Quality Agreement, liaising with SOFIE and partner counsel as needed. • Lead risk assessments for suppliers and materials, integrating risk-based decision making into the supplier lifecycle. Quality Systems Integration • Drive alignment between supplier quality management and broader Quality Management System (QMS) processes (Change Control, Deviation, CAPA, OOS, etc.). • Escalate and manage supplier quality issues to closure, including root cause analysis and corrective actions. • Provide trend reporting and risk metrics to senior leadership. Continuous Improvement • Proactively identify opportunities to strengthen supplier quality processes and enhance regulatory robustness. • Lead initiatives to modernize and streamline supplier management tools, metrics, and reporting. Cross-Functional Collaboration • Partner with Purchasing, Operations, and Corporate QA to ensure supplier reliability, compliance, and business continuity. • Partner with IT and other application specialists to ensure inventory systems (LIMS, SAP, etc.) are used effectively across all business lines. • Engage with senior leadership to communicate supplier risk, strategy, and performance. Qualifications ▪ Bachelor of Science degree in Chemistry, Microbiology, Engineering, Quality/Regulatory Sciences, or related field. ▪ 5+ years of experience in Quality Assurance/Regulatory Affairs in a GMP-regulated pharmaceutical/biologics environment (including at least 3+ years in supplier quality). ▪ 2+ years of supervisory/management experience, with demonstrated success leading teams. ▪ Strong working knowledge of 21 CFR Part 211 and/or 21 CFR Part 212, including practical application in supplier qualification. Working knowledge of EudraLex Volume 4 and ROW regulations preferred. ▪ Demonstrated ability to lead audits, regulatory inspections, and cross-functional initiatives. ▪ Excellent leadership and communication skills. ▪ Ability to manage multiple priorities in a fast-paced environment. ▪ Travel up to 25% (domestic and limited international)

Created: 2026-03-05