BrainChild Bio
Senior Manager / Associate Director, Quality Operations
United States · Director
Sponsorship not specified$30k-$40kDetected 6 days ago
GCPProduct ManagementAuditingLogisticsGMPFDA RegulatoryLeadershipCommunicationCollaborationOrganizational SkillsGxPRegulatory Affairs
About the role
- 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.
- 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).
- Every member of our team plays a direct role in bringing innovative therapies to patients and familiars with urgent unmet medical needs.
Responsibilities
- 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)
- Lead batch disposition activities and quality system elements including deviations and change controls.
- Partner cross-functionally with CMC, Product Operations, Clinical Operations, Regulatory Affairs teams to support comparability, process validation, and product lifecycle activities.
- Support CRO governance and quality management programs.
- Support inspection readiness across clinical operations by leading audit programs, assessing quality risks, and supporting regulatory authority inspections.
- 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.
- 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.
Requirements
- 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
- 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.
- 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.
- Highly organized, team-oriented, and able to work with minimal supervision while maintaining a positive attitude.
Nice to have
- Certification in auditing (e.g., ASQ Certified Quality auditor, or equivalent) or formal FMP/GCP auditing experience.
- Approximately 30-40% travel to CDMOs, CROs, clinical sites, suppliers, and company meetings.
- Bachelor's or Master's degree in Life Sciences, Engineering, or related field
- advanced degree preferred.
Compensation
- $30k-$40k
Company info
- 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.
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