Overview
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.
We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
