Janera Harris

Senior Director of Quality Assurance and Compliance @Satsuma Pharmaceuticals, Inc.

Maintained high standards of Quality in all aspects of GMP and GCP compliance for a drug/device combination product for migraines and ongoing clinical trials. • Provided GxP QA oversight of external vendors’ quality programs, including negotiating, writing, and maintenance of quality agreements, vendor qualification, and compliance. • Release of intermediate, finished product and packaged Investigative Product from 3rd party CMO’s • Managed/conducted external quality audits of clinical investigator sites, clinical and preclinical vendors, third party CMOs and other manufacturing and analytical vendors. • Hosted and participated in mock PAIs for Satsuma and third party CMOs • Lead Management Review meetings with executive level team twice per year • Led selection, planning and rollout for Dot Compliance. One of two administrators of Dot Compliance system at Satsuma. • Supported and authored documentation and execution of Dot Compliance validations to meet 21 CFR Part 11 requirements and user requirements.