Establish and manage a compliant global stability and retain sample program (raw materials, drug substance, drug product, and finished goods) per US 21 CFR 211.170, EU GMP Annex 19, and other applicable regional regulations (UK MHRA, Japan PMDA, Australia TGA, etc.), including defined sample quantities, storage conditions, retention periods, and inventory/chain-of-custody/disposition management, coordinated with international distribution and regulatory affairs for country-specific requirements. Develop, review, and approve stability protocols, study designs, and commitments per ICH Q1A(R2), Q1E, Q5C, and regional guidance; ensure all stability studies (long-term, accelerated, intermediate, in-use, photostability, thermal cycling, transportation/excursion) are executed on schedule across internal labs and external CMOs/CTLs.