Vice President, Quality Control

Establish and lead the global Quality Control strategy, including laboratory infrastructure, testing frameworks, and lifecycle management across development and commercial programs. Provide governance and oversight for QC systems including specifications, test methods, environmental monitoring, stability programs, reference standards, and batch release support. Ensure QC activities are compliant with global regulatory requirements (FDA, EMA, ICH) including cGMP expectations and data integrity standards. Lead method qualification, validation, transfer, and performance monitoring in partnership with Analytical Development. Oversee internal and external laboratory operations, including CROs and CDMOs. Drive QC support for manufacturing operations including in-process, release, and stability testing. Provide leadership for OOS/OOT investigations, deviations, and CAPA implementation. Support regulatory submissions and inspections in collaboration with QA and Regulatory Affairs. Advance QC through digital transformation, automation, and laboratory systems (LIMS, ELN). Build and lead a high-performing QC organization. Manage budgets, capital planning, and resources aligned to program priorities.