Senior Director, Supplier Quality

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Lead the global supplier quality program strategy, governance, and performance management to ensure external suppliers, CMOs, and contract labs meet regulatory, quality, and business requirements for uninterrupted GMP/GDP materials and products. Drive supplier evaluation, qualification, monitoring, and development; guide audit programs and inspections in alignment with major health authorities. As a key member of the quality leadership team, ensure ongoing compliance, quality standards, and inspection readiness of GxP suppliers and partners.

This role is fully remote with about 30% travel, including international travel.

• Global Supplier Quality Strategy & Leadership
  • Shape the global supplier quality strategy to align with corporate and quality objectives.
  • Develop and maintain governance models and performance frameworks for supplier oversight across all regions.
  • Lead and develop a high-performing, geographically dispersed supplier quality team.
  • Define expectations and guidelines for conducting Person in Plant requirements based on data and risk.
• Supplier Qualification & Lifecycle Management
  • Oversee processes for tracking, monitoring, and communicating supplier-related risks to Quality, Compliance, and Global.
  • Influence functional organizations to recognize and address systemic quality issues at external sites and with strategic partners to drive improvements, mitigating risk, and support better inspection outcomes.
  • Ensure risk-based qualification aligned with ICH Q9, ICH Q10, and applicable GMP requirements.
  • Guide and development of supplier risk scoring and segmentation to prioritize oversight and audits.
• Supplier Audits & Compliance Oversight
  • Provide strategic oversight of global audit planning, execution, and follow-up for suppliers, CMOs, and contract labs.
  • Ensure audit observations are addressed effectively, with timely CAPA closure and robust effectiveness checks.
  • Maintain audit programs consistent with FDA, EMA, MHRA, TGA, PMDA, Health Canada, and other health authority expectations.
• Issue Management & Quality Escalation
  • Lead response and escalation processes for supplier deviations, OOS, critical defects, and supply-related disruptions.
  • Serve as key decision-maker and escalation point within cross-functional supplier crisis management.
  • Partner with Procurement, Operations, and Technical teams to resolve supplier quality issues and drive continuous improvement.
• Continuous Improvement
  • Oversee the ongoing optimization within Master Control Supplier Quality and where applicable Audit Module and the ongoing maintenance of program outputs for Supplier Quality.
  • Create a living Quality Transformation plan around Supplier Quality Initiatives with internal and external actions.
  • Drive implementation of digital tools for supplier monitoring (e.g., eQMS modules, audit management, scorecards).
  • Implement industry best practices for advanced quality analytics, predictive risk modeling, and supplier quality modernization.
• Collaboration and Communication
  • Coordinate with Manufacturing and other key business partners to maintain a lifecycle approach to supplier and strategic partner relationships.
  • Lead the management of the master supplier list for the entire company.
  • Lead cross-functional teams in Quality improvement initiatives.

• Required:
  
  15+ years of experience in GMP operations within the pharmaceutical or biotech industry.
• Required:
  
  7+ years of leading global teams in the pharmaceutical or biotechnology industry.
• Required:
  
  10+ years in GMP supplier quality, external manufacturing, material quality, or technical quality leadership.
• Required:
  
  Proven track record leading global teams and scaling global supplier quality programs.
• Required:
  
  Strong knowledge of GxP regulations.
• Required:
  
  Skilled at leading teams through ambiguity and driving decisive action.
• Required:
  
  Strong collaboration with Procurement, Operations, Technical Services, Regulatory, and Supply Chain.
• Required:
  
  Proven leadership experience in managing cross-functional teams in a quality-related environment as well…