Senior Manager / Associate Director, Quality Operations

BrainChild Bio is seeking a Senior Manager/Associate Director, Quality Operations to lead quality oversight of outsourced clinical and manufacturing operations supporting cell therapy programs from patient collection through product administration. This is a key role in the Quality organization and plays a critical part in ensuring the highest standards of quality, compliance, and patient safety. 

The successful candidate will establish and maintain a robust supplier quality management program, oversee GxP compliance across external partners, drive quality risk management and inspection readiness, and partner cross-functionally to ensure reliable and safe product supply across various programs. 

BrainChild Bio is a clinical-stage biotechnology company leading the field in the development of CAR T cell therapies for tumors in the central nervous system (CNS). We are kids-first, prioritizing devastating pediatric brain tumors, with a pipeline that extends our technology platform to adult indications, including glioblastoma and brain metastases. Every member of our team plays a direct role in bringing innovative therapies to patients and familiars with urgent unmet medical needs.  

Responsibilities: 

External Quality  

• Provide Quality oversight for GxP Partners, Suppliers & service providers. (CDMOs, CROs, central laboratories, apheresis centers, logistics providers, and clinical sites.) 

• Lead the qualification, onboarding, performance monitoring, and lifecycle management activities of GxP suppliers and services providers including CDMOs, CROs, central laboratories, apheresis centers, logistics providers, and clinical sites. 

• Accountable for Quality Agreements & risk-based oversight plans for GxP Partners, Suppliers and service providers. 

• Lead supplier audits, supplier Quality Business Reviews (QBRs)  

• Ensure effective management of supplier deviations, investigations, CAPAs, change controls.  

GMP Quality Operations 

• Provide quality oversight across the entire cell therapy journey, from patient collection through product administration, supporting clinical development, pivotal studies, and commercial readiness. 

• Provide quality oversight of outsourced manufacturing operations supporting clinical and commercial readiness activities. 

• Lead batch disposition activities and quality system elements including deviations and change controls. 

• Ensure product operations activities comply with applicable GMP, ICH, regulatory requirements. 

• Partner cross-functionally with CMC, Product Operations, Clinical Operations, Regulatory Affairs teams to support comparability, process validation, and product lifecycle activities. 

• Ensure timely escalation and resolution of significant quality and patient safety issues while promoting a proactive culture of quality and continuous improvement.   

Clinical Quality  

• Provide quality oversight for clinical trial execution and governance of outsourced clinical activities to ensure compliance with GCP and applicable regulatory requirements. 

• Support CRO governance and quality management programs. 

• Ensure app