Note: The job is a remote job and is open to candidates in USA. 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). They are seeking a Senior Manager/Associate Director, Quality Operations to lead quality oversight of outsourced clinical and manufacturing operations supporting cell therapy programs, ensuring the highest standards of quality, compliance, and patient safety.
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)
- Ensure effective management of supplier deviations, investigations, CAPAs, change controls
- 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
- 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
Skills
- 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
- Certification in auditing (e.g., ASQ Certified Quality auditor, or equivalent) or formal FMP/GCP auditing experience
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