- Set and execute global analytical development and quality control strategy aligned with corporate and CMC objectives.
- Oversee GMP analytical operations, inspection readiness, data integrity, PAI readiness, and regulatory compliance.
- Lead analytical method development, validation, transfer, and lifecycle management, initially focused on small-molecule oral solid dosage products.
- Own dissolution strategy and the dissolution data package for CVM submissions.
- Author and review analytical content for NADA CMC sections, including validation summaries, specification justifications, stability narratives, and deficiency responses.
- Lead drug substance analytical strategy, including specifications, impurity control, stability programs, reference standards, and supplier testing.
- Own stability strategy, including protocol design, statistical evaluation, shelf-life assignment, and trending.
- Establish commercial QC operations and oversee external GMP testing laboratories and service providers.
- Oversee analytical and QC deviations, investigations, OOS/OOT events, and CAPAs; engage with FDA CVM and other regulatory agencies.
- Build and lead the QC and analytical development organization, manage external partners, and plan resources and budgets.