Senior Manager, Quality Chemistry Manufacturing and Controls (CMC) Drug Product (DP)

Reports to: Director, Quality CMC

Location: Remote work, US Only

Why Sabin:

Our mission is to make vaccines more accessible, enable innovation, and expand immunization across the globe. We seek a future free from vaccine-preventable diseases. We are an innovative, collaborative, and engaged team that values accountability, teamwork, partnership, and driving impact. We are vaccine champions improving lives through immunization. Sabin staff, management, and the Board of Trustees are committed to ensuring that fairness, integrity, and opportunity remain at the core of how we operate.

Position Summary:

The Senior Manager, Quality CMC DP serves as primary Quality representative supporting vaccine DP manufacturing from clinical development through late-stage development, Process Performance Qualification (PPQ) readiness, licensure preparation, and commercialization. The role provides current Good Manufacturing Practices (cGMP) quality oversight for external DP manufacturing, aseptic processing, fill-finish operations, technology transfer, process validation, PPQ, commercial readiness, inspection readiness, and product disposition activities.
This position partners with CMC and Regulatory Affairs and external manufacturing organizations to ensure compliant manufacture, testing, release, and lifecycle management of vaccine DP in accordance with global cGMP requirements and regulatory expectations. The successful candidate will possess extensive DP quality experience supporting technology transfer, process validation, PPQ execution, health authority interactions, and commercialization readiness while ensuring manufacturing systems and quality processes remain compliant, scalable, and inspection ready.

Key Responsibilities:

• Serve as primary Quality representative, providing cGMP oversight and risk-based quality decision-making across clinical and late-stage DP activities.
• Provide Quality oversight for clinical manufacturing, engineering runs, technology transfer, scale-up activities, process validation, and PPQ readiness.
• Participate in manufacturing readiness reviews and provide Quality approval for validation, media fills, PPQ execution, and commercial readiness activities.
• Review batch records, deviations, investigations, analytical and stability data, environmental monitoring results, and change controls to support product disposition decisions.
• Approve deviations, Corrective and Preventative Actions (CAPAs), change controls, risk assessments, and quality records supporting compliant operations.
• Provide Quality oversight of Contract Development Manufacturing Organizations (CDMOs) and contract laboratories, including supplier qualification, audits, inspection support, and CAPA implementation.
• Support preparation of quality documentation and responses associated with Biological License Application (BLA), Marketing Authorization Application (MAA), and other regulatory submissions.
• Support regulatory inspections, including the Food and Drug Administration (FDA) inspections, Bioresearch Monitoring (BIMO) inspections, and Pre-Approval Inspections (PAIs).
• Lead the development, implementation, and continuous improvement of Sabin's Quality Management System, quality governance, and sponsor oversight processes to support the organization's transition to a fully compliant global Marketing Authorization Holder (MAH).