Senior Analyst, Quality Systems

Role: Senior Analyst, Quality Systems at Johnson & Johnson, focusing on supporting and executing quality system activities within Advanced Therapies (AT) operations. Responsibilities: manage document and data integrity processes, act as a site superuser, support audit and investigation activities, lead process improvement initiatives, and update SOPs; serve as liaison between Raritan AT site and global platforms; elevate quality risks and support compliance with cGMP and FDA/EU regulations. Requirements: bachelor’s degree in engineering, science, or related technical field; minimum 4 years of experience in Quality Assurance or Quality Systems; strong knowledge of cGMP, regulatory guidance, and audit participation; excellent communication and collaboration skills; ability to support off-shift activities. Preferred: experience in a fast-paced manufacturing environment. High-Value: biologics or advanced therapies manufacturing environment, global compliance focus, cGMP proficiency, and cross-functional collaboration within a regulated biopharma setting. Work setup: based in Raritan, NJ, with flexibility for occasional off-shift support.