$150,000 - $160,000 yearly
Arcutis Biotherapeutics Inc
Westlake Village, CA, USA
The Senior Manager Quality Control , under the direction of the Director, will be responsible for planning, implementing and managing initiatives for Arcutis and will proactively oversee the Quality Control program for compliance with ICH/FDA/EMA Guidelines. They will work closely with internal and external team members to meet Company timelines and objectives for Arcutis drug products, as well as preparation of CMC sections for regulatory submissions and responsible for participating in and supporting novel drug development projects. Roles & Responsibilities Manage the QC testing and release process for commercial topical products, ensuring timely lot disposition.Review and approve batch records, Certificates of Analysis (CoA), analytical test results, and stability data to ensure compliance with regulatory and product specifications.Coordinate with QA, Manufacturing, and Regulatory Affairs to resolve deviations, Out-of-Specification (OOS) results, and...