Moderna Therapeutics - Norwood, MA
posted 4 months ago
The Associate Director, QA Operations at Moderna, Inc. is a pivotal role that reports directly to the Director of QA Drug Product. This position is responsible for leading the quality and compliance readiness for a cutting-edge Drug Product (Fill Finish) cGMP manufacturing facility. The primary focus is to ensure operational readiness for the production of both clinical and commercial drug products while strictly adhering to current Good Manufacturing Practices (GxP), corporate policies, regulatory requirements, and industry best practices. This role encompasses providing cross-functional support for Commissioning, Qualification & Validation (CQV) activities that are essential during the facility start-up phase. The Associate Director will execute a comprehensive project quality plan that includes regulatory inspection readiness. This involves liaising with key stakeholders to navigate the facility integration strategy and ensuring that the appropriate quality systems and operational processes are developed, implemented, and maintained for a seamless start-up and routine operation of the facility. Once the facility is operational, this role will provide end-to-end quality oversight for drug product operations, ensuring compliance with cGMPs, company procedures, and regulatory requirements. In this capacity, the Associate Director will play a crucial role in establishing the operational strategy, implementing best practices, and building a high-performing team to achieve excellence in manufacturing operations while maintaining regulatory compliance and quality standards. The individual will be at the forefront of Moderna's mission to deliver mRNA therapies to patients worldwide, utilizing their expertise to ensure the smooth operation of manufacturing processes that directly contribute to the production of transformative therapies for patients.