Moderna Therapeutics - Cambridge, MA
posted 4 months ago
Moderna is seeking a Director, PV Operations Compliance, Alliance, and Process Excellence responsible for ensuring the highest level of compliance as part of Moderna's Pharmacovigilance Quality Management System. This role involves providing oversight of commercial programs, establishing a framework for affiliate PV standards, and managing business continuity. The individual will report to the Sr. Director, PV Operations- Compliance, Alliance, and Process Excellence. The Director will define, drive, and implement the PV strategies for process standards across the PV system to ensure compliance and standardization, supporting Moderna's evolving market presence through innovation and technology. This position is critical as Moderna expands its product reach globally and accelerates its pipeline and late-phase development, positioning the company for substantial growth in the upcoming years. The Director will be a key contributor to Moderna's future success in making a transformative impact on patients through its mRNA-based vaccines and therapeutics. The responsibilities include overseeing the development and implementation of frameworks for managing commercial programs, ensuring pharmacovigilance compliance and inspection readiness, and collaborating with various functional areas to maintain a robust pharmacovigilance system. The Director will also provide oversight for the development of relevant KPIs, processes, and systems, manage the review and approval of commercial programs, and lead strategic initiatives to identify gaps and areas of improvement within the PV system. This role requires building strong relationships with internal and external stakeholders and maintaining up-to-date knowledge of global regulatory requirements. The Director will also serve as a subject matter expert for PV, providing guidance on quality and compliance issues, and will engage externally to benchmark and leverage best practices.