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 appropriate escalation and management of critical quality and patient safety issues. 

• Support inspection readiness across clinical operations by leading audit programs, assessing quality risks, and supporting regulatory authority inspections. 

Qualifications: 

• Bachelor’s or Master’s degree in Life Sciences, Engineering, or related field; advanced degree preferred. 

• 8-10+ years of progressive quality leadership experience in cell therapy, biotechnology, or biologics, and at least 5 years in cell therapy, including leadership responsibilities in GMP and/or GCP environments. 

• Demonstrated expertise in cell therapy or ATMP manufacturing & In-depth understanding of GxP quality systems, including GMP, GCP, ICH, FDA regulations, and global regulatory requirements 

• Demonstrated success leading QA operations, with compliance oversight of external manufacturing and technical operations. 

• Demonstrated experience overseeing CDMOs, CROs, CTLs, logistics providers, & GxP suppliers. 

• Experience supporting regulatory inspections and health authority interactions, with a demonstrated ability to maintain inspection readiness. 

• Excellent leadership, communication, and cross-functional collaboration skills, with the ability to influence internal and external stakeholders.  

• Demonstrated ability to prioritize competing demands, solve complex quality issues, and thrive in a fast-paced, evolving environment. 

• Highly organized, team-oriented, and able to work with minimal supervision while maintaining a positive attitude. 

Preferred Qualifications 

• Certification in auditing (e.g., ASQ Certified Quality auditor, or equivalent) or formal FMP/GCP auditing experience.  

Travel 

• Approximately 30-40% travel to CDMOs, CROs, clinical sites, suppliers, and company meetings.