Manager / Senior Manager

Job Description

This position is a Corporate Quality function and is a bridge between departments, CMOs and sites respective to the writing, tracking and communicating of reportable events and ensuring timely submission of Field Alerts (FAR/BPDR) and Illegitimate Drug Notifications to FDA. This position performs the functions of author, coordinator, and issuer, as needed. This position is responsible for recognizing and understanding preexisting or potential future events or issues that may warrant submission of a Field Alert (FDA 3331a) or Illegitimate Drug Notification (FD 3911) forms to FDA. This position shall assess and advise quality management of potential emerging trends and issues that may compromise Amneal s compliance standing, customer experience or company reputation. This role provides corporate quality support and leadership with the determination and implementation of appropriate CAPAs stemming from Field Alert investigations to prevent recurrence and implement CAPAs across Amneal sites and/or product lines as applicable. This individual is expected to work independently and with others in a dynamic, high paced and highly interdisciplinary environment to ensure Field Alert and Illegitimate Drug Notification reportable events and issues are processed in a compliant manner and within defined timelines. Maintain dashboards metrics and assess for the existence or potential for reportable conditions. Partner with Cross Functional Departments to create, monitor and submit Field Alerts forms. Monitor for the existence of adverse trends, signals or pattens that could cause the need for market action. Maintain folders for each FAR to include forms, communications, reports etc. as applicable. Keep tracker up to date, schedule follow up meetings and communicate timelines. Write and/or maintain SOPs with current regulatory and Amneal procedural needs and requirements.