Senior Quality Operations Manager

Role: Senior Quality Operations Manager overseeing external manufacturing and supply chain partners in a biopharma setting. Objectives: ensure compliance with cGMP standards, manage quality issues, and support technology transfers and analytical activities. Responsibilities: provide daily QA oversight of CMOs, suppliers, and labs; manage quality agreements, deviations, investigations, CAPAs, and change controls; oversee analytical method transfers, validations, and stability programs; support audits, inspections, and quality reviews; monitor quality metrics and drive continuous improvement. Qualifications: bachelor’s degree in life sciences, chemistry, engineering, or related, with 8+ years of QA experience in pharma/biotech; experience with CMOs, regulatory compliance, and quality systems; strong knowledge of cGMP, deviations, investigations, and analytical QC; excellent project management, communication, and stakeholder management skills; ability to travel up to 25%. HighValue: biopharma manufacturing, external supply oversight, cGMP compliance, analytical validation, and regulatory readiness. WorkSetup: hybrid in Waltham, MA or Newark, CA with 2-3 onsite days per week.