Quality & Regulatory Affairs Specialist
Core
Technical backbone for Product Operations, overseeing production quality, stability testing, and regulatory compliance for DTC health supplement brands.
Role type
Senior individual-contributor Quality & Regulatory Affairs Specialist
Builds
Finished-goods supplement products for global DTC customers
Domain
Consumer Health & Wellness / Dietary Supplements
Deliverable
physical/clinical work
Required skills
Production quality oversight, CMO/CDMO management, stability testing interpretation, US ingredient regulatory compliance (NDI/GRAS), adverse event reporting, claims evidence generation
Preferred skills
Probiotic or botanical testing data interpretation, direct facility auditing, third-party lab/CRO study management
Technologies
Batch record systems, CAPA management tools, stability testing protocols
Responsibilities
Diagnose and resolve production quality issues with CMO partners; review QC and consolidate batch records; manage accelerated and real-time stability programs; determine NDI/GRAS/ODI status and maintain ingredient dossiers; scope and manage benefit/proof studies with CROs; hold finished-goods release sign-off
Seniority
Senior, hands-on IC
