Senior Director, Supplier Quality

Role Summary

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.

Responsibilities

• 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.

Qualifications

• 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 as managing strategic partner accountabilities from a supplier quality perspective.
• Required: Excellent communication and interpersonal skills.
• Required: Strong analytical and problem-solving abilities.
• Required: Ability and willingness to travel as needed.

Education

• Bachelor’s degree in Life Sciences, Engineering, or a related discipline; advanced degree preferred.

Skills

• Inclusive mindset: Demonstrate understanding and appreciation for diversity, and actively work to create an inclusive environment.
• Creativity and innovation: Willingness to think outside the box and develop creative solutions.
• Commitment to excellence: Strive for excellence in all work.
• Results-oriented: Focus on delivering measurable results.
• Ethical behavior: Act with integrity in all interactions.
• Adaptability: Able to adjust to changing priorities and challenges.
• Strong communication skills: Communicate effectively with colleagues and stakeholders at all levels.
• Collaboration: Work effectively as part of a team and share knowledge.
• Resilience: Bounce back from setbacks and persevere.
• Continuous learning: Commit to ongoing professional development.

Additional Requirements

• Travel: Ability and willingness to travel as needed (approximately 30%), including international travel.