The Senior Program Manager, Sterile NPI, will lead the end-to-end product development and launch processes for sterile pharmaceutical products and facilities, ensuring timelines, budgets, and quality standards are met, supporting both the VP, Innovation and embedded within the Operations & Innovation Program Management Office (PMO). This role involves managing teams remotely and on-site, requiring up to 25% travel.
The Quality Documentation Specialist will oversee specifications, regulatory compliance, and change management for Clean Simple Eats products, functioning as the company specification lead. They will collaborate with internal and external partners to ensure data accuracy, implement data management changes, and review data related to product claims validation. Additionally, they will ensure compliance with North American finished product labeling regulations.
As a Post-Market Surveillance Analyst, you'll be an essential part of the Quality Team, supporting the operational integrity of the Post-Market Surveillance system within the Quality Management System. You'll meticulously manage the quality of complaint records, ensuring their completeness and consistency prior to closure. The role demands a deep understanding and precise application of diverse regulatory requirements.