2 regulatory compliance internal audit jobs found in Providence

Location : Princeton, NJ onsite About Summit: Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs. At Summit, we believe in building a team of world class professionals who are passionate about this mission, and it is our people who drive this mission to reality. Summit’s core values include integrity, passion for excellence, purposeful urgency, collaboration, and our commitment to people. Our employees are truly the heart and soul of our culture, and they are invaluable in shaping our journey toward excellence. Summit’s team is inspired to touch and help change lives through Summit’s clinical studies in the field of oncology. Summit has multiple global Phase 3 clinical studies, including: Non-small Cell Lung Cancer (NSCLC) HARMONi: Phase 3 clinical study which was intended to evaluate ivonescimab combined with...

The Manager, Manufacturing Product Quality (Small molecule) is responsible for ensuring GMP compliance in the manufacturing packaging, labeling, and distribution of commercial and clinical trial materials across global operations. This role supports the oversight of manufacturing and packaging activities performed internally and at external vendors, ensuring that quality standards are met and regulatory requirements are maintained throughout the commercial and clinical supply chains. The manager will collaborate with cross-functional teams including Clinical Operations, Regulatory Affairs, and Supply Chain to ensure the integrity and traceability of investigational products from manufacturing and packaging through delivery. Key Responsibilities Oversee manufacturing of commercial and clinical products at contract manufacturers to ensure compliance with GMP, and applicable global regulatory requirements. Performs batch record review and quality release...