New Products and Business Quality Lead
Core
Lead quality due diligence, supplier qualification, and commercial readiness for new products and partners in pharmaceutical development and manufacturing.
Role type
Senior Quality Lead (New Products & Business Quality)
Builds
New pharmaceutical products, devices, and APIs; external supplier and partner networks.
Domain
Pharmaceutical industry (small and large molecules, vaccines, devices, API)
Deliverable
client delivery | infrastructure
Required skills
Quality due diligence, supplier qualification, Quality Agreements negotiation, third-party assessments (sterility, data integrity), Quality by Design (QbD), cGMPs, global regulations (FDA/EMA), project leadership, cross-functional collaboration, information systems management
Preferred skills
Aseptic manufacturing, API/DP/Biotech/Oral Solid Dosage experience, diverse leadership and coaching, influencing peers
Technologies
Informational Systems and Databases used by Quality Assurance
Responsibilities
Conduct quality due diligence assessments of potential third parties; lead qualification and onboarding of new suppliers and partners; negotiate Quality Agreements; conduct third-party assessments (Sterility Assurance, Quality Culture, Data Integrity); support technology transfers and co-development initiatives; ensure seamless transition to commercial oversight; support site divestiture integration; lead quality system improvements.
Seniority
Senior, hands-on IC with strategic oversight
