Compliance Specialist I

Lead weekly Compliance Topics Forum to research, assess, and facilitate resolution of compliance activities including Risk Assessments and notifications. Serve as a compliance resource for the TS Audit Team by maintaining relationships with internal RA/Safety and external consultants. Provide backup for OTC stability study sample preparation, testing, and reporting while managing GMP registration, site licensing, and license renewal calendars. Support the Quality Management Team by researching GMP Registration pathways and gathering evidence for third-party MFRs. Respond agilely to critical product troubles and urgent Regulatory Agency directives. Maintain subject matter expertise by monitoring compliance forums, attending industry meetings, and obtaining necessary training. Coordinate pan-regional GMP registration and facilitate compliance-related invoicing across various legal entities. Manage systems for compliance activities and act as the Quality Management liaison to the QM/RA forum.