CMC Project Manager- FSP

The CMC Project Manager will participate in the development and maintenance of an effective change control system for CMC-related changes, coordinate and document CMC changes ensuring compliance with regulatory and quality requirements, support cross-functional teams in planning and executing CMC-related lifecycle management projects, facilitate communication between stakeholders, develop project plans, track progress, identify risks, and develop mitigation strategies, facilitate project meetings, review and approve change control documentation, maintain comprehensive records, prepare regular reports, identify opportunities for process improvements, implement best practices and SOPs, and train staff on change control processes and regulatory requirements.