Quality Analyst, Quality Assurance

BrainChild Bio is seeking a Quality Analyst, Quality Assurance, to support Quality activities across our clinical-stage cell therapy programs. BrainChild Bio is a kids-first company focused on developing innovative cell therapies for patients with devastating diseases, and this role plays a critical part in ensuring that every product delivered meets the highest standards of quality, safety, and reliability.

The Quality Analyst will contribute to Quality Assurance oversight of manufacturing and testing activities performed both internally and at contract manufacturing partners (CDMOs). This individual will provide hands-on operational Quality support, partnering closely with BrainChild Bio’s Quality, Patient Operations, and Program Management teams to help track and support in-process autologous CAR T batches, where each batch represents an individual patient.

Key areas of focus include documentation review, batch tracking, and supporting timely lot disposition and product shipment to ensure therapies reach patients without delay.

The ideal candidate is detail-oriented, highly organized, and motivated by the opportunity to make a direct impact on patients’ lives. This role offers the opportunity to work cross-functionally and gain exposure to cell therapy manufacturing, GMP Quality systems, and external partner management in a fast-paced biotech environment.

Responsibilities:

· Support Quality review of batch records, test results, and associated documentation to enable timely lot disposition.

· Assist in tracking manufacturing, testing, and release activities for clinical batches to support timely and compliant product delivery to patients.

· Coordinate with internal teams (Quality, Patient Operations, Program Management) and external partners, including CDMOs, to track batch status and communicate timelines and issues.

· Support Quality oversight activities to ensure compliance with applicable GMP regulations across internal operations and external partners.

· Assist with deviation, investigation, and CAPA tracking and follow-up.

· Contribute to tracking and reporting of key Quality and operational metrics.

· Assist in preparation of materials for Quality Management Reviews and internal reporting.

· Participate in inspection readiness activities and support audit preparation efforts.

· Provide general Quality support to ongoing manufacturing and development activities as needed.

· Provide support to ensure compliance of the Quality Management System and associated documentation.

· Support Internal Audit processes

· Travel required: 20%-40%

Qualifications:

· Bachelor’s degree in life sciences or related field.

· 4–7 years of experience in a Quality or GMP-regulated environment (biotech, pharma, or cell/gene therapy preferred).

· Familiarity with GMP principles and documentation practices.

· Strong attention to detail, organizational skills, and ability to manage multiple priorities.

· Effective communication skills and ability to work cross-functionally.

· Experience supporting manufacturing or working with external partners (e.g., CDMOs) is a plus.

· Ability to thrive in a fast-paced, mission-driven, small company environment and adapt to shifting priorities.