Director, PV Operations Compliance, Alliance, and Process Excellence

Moderna Therapeutics - Cambridge, MA

Full-time - Senior

Cambridge, MA

Professional, Scientific, and Technical Services

About the position

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.

Responsibilities

• Oversee the development and implementation of frameworks for the management of commercial programs (i.e., PSPs, MRPs, Digital Initiatives), business continuity, and global country operations to ensure pharmacovigilance compliance and inspection readiness.
• Collaborate with PV functional areas and other departments (Pharmacovigilance Quality, Global Regulatory Sciences, Clinical Development, Medical Affairs, Commercial) to ensure a robust pharmacovigilance system at Moderna.
• Provide oversight for the development of relevant KPIs, processes, and systems.
• Oversee and manage the review and approval of commercial programs, providing PV expertise and ensuring fit-for-purpose solutions to secure compliance.
• Oversee the establishment of the BCP process, and function as the BCP Lead.
• Ensure testing of the Global BCP in collaboration with PV SMEs/Functional leads.
• Provide strategic oversight in the development of frameworks for relevant PV system processes for implementation across geographies to ensure consistency.
• Identify gaps and areas of improvement within the PV system and lead strategic initiatives to address them.
• Lead process improvements, including the creation and updating of relevant PV procedures to drive overall CSPV strategies.
• Provide strategic oversight in defining and implementing strategies and action plans for risk management across the PV system globally.
• Collaborate with Head of Regions and QPPV to ensure the establishment of a robust local PV system.
• Build strong, open, and collaborative working relationships with both internal and external stakeholders and matrixed project teams.
• Maintain up-to-date knowledge of global regulatory requirements.
• Lead internal and external interactions to ensure quality, compliance, and standardization.
• Provide input into business strategy as it relates to compliance and policy.
• Engage externally to ensure ongoing benchmarking and the leveraging of best practices.
• Serve as SME for PV to provide guidance for quality and compliance issues, procedural/policy impact, and inspection readiness.
• Serve as a deputy for Head of Compliance, Alliance, and Process Excellence as needed.
• Collaborate cross-functionally to foster a culture of compliance and quality first time right.

Requirements

• Bachelor's degree (preferably in a science or health-related field) and a master's preferred.
• A minimum of 7-10 years of experience in Pharmacovigilance, with demonstrated strategic leadership in Pharmacovigilance Operations and PV affiliate Operations.
• Expertise in PV regulations and implementation of PV processes.
• Significant experience in the management of commercial programs and oversight for PV controls.
• Experience with Health Authority Inspection interviews/process and management.
• Strong communication skills and ability to partner closely and effectively cross-functionally and cross-regionally.
• Experience working with all levels of management and consulting with key business stakeholders, including an ability to influence outcomes.
• Excellent interpersonal skills, ability to develop relationships with key stakeholders, conflict management and negotiation skills, and ability to identify issues and raise them to key stakeholders to develop relevant and realistic plans, programs, and recommendations.
• Excellent analytical skills and an ability to communicate complex issues simply and propose solutions.
• Ability to manage multiple, complex projects in a fast-paced environment.

Benefits

• Free parking
• Paid parental leave
• Disability insurance
• Health insurance
• Dental insurance
• Flexible spending account
• Paid time off
• Parental leave
• Vision insurance
• 401(k) matching
• Sabbatical