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