Ensure labeling meets global regulatory requirements (FDA, EMA, Annex 13, country-specific rules) and support IND/BLA filings and inspections Establish validation strategies ensuring 21 CFR Part 11 and GMP compliance, including review and approval of IQ/OQ/PQ and vendor validation documentation Packaging Design, qualify, and validate patient-specific, temperature-controlled packaging systems (cryogenic shippers, LN2 dewars, ambient kits; e.g., -150°C vapor phase LN2, refrigerated) to maintain chain of identity and product integrity. Manager, Packaging & Labeling serves as the primary technical expert for the design, qualification, and technology transfer of clinical and commercial label, artwork, and packaging configurations across our global network of Contract Development and Manufacturing Organizations (CDMOs), ensuring robust chain of identity (COI) and chain of custody (COC) throughout.