Associate Director of Supplier Quality

Responsibilities Lead and manage internal, supplier, client, and regulatory audit programs across GMP manufacturing operations Serve as the primary point of contact during FDA, EMA, and other global regulatory inspections Coordinate audit preparation activities, back‑room support, responses to observations, and CAPA implementation efforts Build, mentor, and develop high‑performing Quality and Supplier Quality teams within a fast‑paced manufacturing environment Drive strategic workforce planning, succession planning, and technical capability development across the Quality organization Oversee supplier qualification programs, including risk assessments, vendor onboarding, supplier performance monitoring, and ongoing compliance activities Plan and conduct supplier audits, including pre‑qualification, surveillance, and for‑cause audits across raw materials, components, and contract service providers Partner closely with Manufacturing, Supply Chain, Engineering, Validation, and Technical Operations teams to support operational excellence initiatives Manage supplier changes and associated quality risk assessments to minimize supply chain disruptions and maintain regulatory compliance Support development and continuous improvement of quality systems, audit programs, and inspection readiness strategies Develop training programs and strengthen technical expertise related to sterile manufacturing, aseptic processing, and pharmaceutical quality systems Drive continuous improvement initiatives focused on compliance, efficiency, quality culture, and long‑term operational scalability Qualifications 8–10+ years of experience within pharmaceutical, biotech, biologics, or other highly regulated GMP manufacturing environments Strong background in Quality Assurance, supplier quality management, auditing, and regulatory compliance 5+ years of leadership experience managing, mentoring, and developing Quality professionals Experience supporting FDA, EMA, MHRA, or other global regulatory inspections and client audits Strong understanding of supplier qualification, vendor oversight, deviations, CAPAs, change controls, and risk management methodologies Experience within sterile manufacturing, aseptic processing, injectable products, biologics, or parenteral manufacturing environments preferred Familiarity with validation principles, data integrity expectations, and pharmaceutical quality systems Lean Six Sigma, ASQ certifications, or other continuous improvement experience is a plus Excellent communication and leadership skills with the ability to interact effectively with executive leadership, regulatory agencies, suppliers, and cross‑functional stakeholders #J-18808-Ljbffr Harba