Indivior
Hull, MA, USA
TITLE: Director, FCP Quality, Compliance & Licensing ESSENTIAL FUNCTIONS: The responsibilities of this job include, but are not limited to, the following: Ensures all functions within the GxP business understand their role in delivering Quality Patient Care. Ensures all applicable licensing is current and meets regulatory, state and market requirements. Maintenance and development of Area and local Indivior Pharmaceutical Quality System (policies, procedures and working practices) to meet Indivior and Competent authority requirements. Integrates quality oversight and operations effectively with global Quality Operation, Site Quality, Global Audits and Quality Systems & OPEX teams to ensure compliant, yet efficient release and disposition of products globally. Accountability for key metrics (KPIs) in relation to third party API operations and FDP dispositions, periodic quality reports, and audits as needed. Hosting regulatory inspections, supporting internal...