Director of Supplier Quality Management & CDMO Oversight

Lantheus
Any Location, MA
Job Description
The Director of Supplier Quality Management & CDMO Oversight is a senior quality leader responsible for establishing and executing the strategy that ensures all external partners—including Contract Development and Manufacturing Organizations (CDMOs), raw material suppliers, packaging vendors, and critical service providers—consistently deliver safe, compliant, and high‐quality pharmaceutical products.

Requirements

  • Lead the Supplier Quality Management function for Lantheus, setting a clear vision, strategy and process for the harmonized quality management of suppliers, contractors and consultants.
  • Develop and execute the global Supplier Quality and CDMO oversight strategy aligned with corporate quality objectives.
  • Establish and lead a comprehensive external quality governance model, including Quality Business Reviews, performance scorecards, and risk-based oversight plans.
  • Serve as the senior quality representative for external manufacturing within cross-functional leadership forums.
  • Oversee the qualification, approval, and periodic re-evaluation of CDMOs, raw material suppliers, and service providers.
  • Ensure quality agreements are established, maintained, and effectively implemented.
  • Provide quality oversight for all externally manufactured drug substances, drug products, intermediates, and clinical supplies.
  • Ensure robust management of deviations, investigations, CAPAs, change controls, and batch disposition activities.
  • Partner with CDMOs to ensure process robustness, data integrity, and adherence to cGMP and regulatory requirements.
  • Support technology transfers, scale-up activities, and process validation at external sites.
  • Lead quality risk assessments for external partners and implement mitigation strategies.
  • Drive continuous improvement initiatives across the external supply network to enhance quality performance and reliability.
  • Monitor and analyze supplier performance metrics, identifying trends and opportunities for improvement.
  • Ensure CDMOs and suppliers are inspection-ready and compliant with global regulatory expectations (FDA, EMA, MHRA, etc.).
  • Partner closely with Technical Operations, Supply Chain, Regulatory Affairs, Procurement, and Quality Assurance to ensure seamless external manufacturing operations.
  • Develop and maintain a strong partnership with key suppliers and act as the primary conduit for quality related issues from suppliers, contractors and consultants.
  • Partner with Procurement and R&D, at an early stage, to identify development as well as commercial suppliers and contractors for new product introduction programs and redundancy in supply.
  • Act as the primary Quality representative for supplier management projects to support cost control programs, inventory management planning and compliance and business risk mitigation programs.
  • Oversee and ensure adherence to supplier quality management budget plan

Benefits

  • Comprehensive health benefits package that includes medical, prescription drug, dental, and vision coverage.
  • Life and disability benefits.
  • Pre-tax accounts.
  • 401(k) with company contribution.
  • Paid vacation, holidays, sick days, and paid parental leave.
]]>