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%

Bachelor’s degree in life sciences or related field.
1–3 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.

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