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.