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You'll be the primary regulatory CMC voice on cross-functional matrix teams, covering everything from early clinical trial applications through to new marketing authorizations, post-approval changes, and full lifecycle management. That means you won't
Leads and handles all Quality & Compliance related programs supporting manufacturing, testing and release. This includes the clinical and commercial manufacturing and testing in full compliance with all J&J and governmental environmental, health, safety,
The incumbent is responsible for conducting audits with an emphasis on Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) quality systems that govern compliance programs for PTC commercial and clinical activities in both the small