Senior Quality Operations Manager

Role: Senior Quality Operations Manager overseeing external manufacturing and supply chain partners in a biopharma setting, ensuring compliance with cGMP and global regulations. Responsibilities: provide day-to-day quality oversight of CMOs, suppliers, and labs; manage quality agreements, deviations, investigations, CAPAs, and change controls; oversee technology and analytical transfers, validation, and manufacturing readiness; support quality reviews, metrics, audits, and regulatory inspections; communicate risks and collaborate cross-functionally to maintain compliant product supply. Requirements: bachelor's degree in life sciences, chemistry, engineering, or related field; 8+ years in pharmaceutical or biotech quality roles; experience managing external partners; strong knowledge of cGMP, quality systems, and global regulations; familiarity with deviations, investigations, CAPAs, tech transfers, and analytical operations; excellent project management and communication skills; ability to travel up to 25%. HighValue: experience in external quality oversight, cGMP compliance, analytical transfer, validation, and regulatory inspection support, in the context of biopharma manufacturing. WorkSetup: hybrid in Waltham, MA or Newark, CA with 2-3 days onsite.