Job Description

Position Summary Aruna Bio is a clinical-stage biotech company advancing a new class of cell-free biologics – exosomes – for the treatment of central nervous system and neurodegenerative disorders. We're looking for a Quality Assurance Manager to join our team in support of continued development of AB126, our lead therapeutic exosome candidate. The Quality Assurance (QA) Manager serves as the independent quality oversight authority within Aruna Bio and is responsible for ensuring that all activities related to Good Manufacturing Practice (GMP) compliant manufacturing, quality control (QC), and applicable clinical quality operations comply with internal quality standards and regulatory requirements, including GMP, Good Clinical Practice (GCP), and Food and Drug Administration (FDA) regulations. As Aruna Bio advances into Phase 1b clinical studies and scales its GMP manufacturing capabilities, the QA Manager ensures that quality systems, operational processes, and controlled documentation remain compliant, inspection-ready, and aligned with evolving regulatory expectations. This position plays a critical role in safeguarding product quality, maintaining audit readiness, and ensuring that clinical and manufacturing activities are executed with the highest level of integrity and control. Core Responsibilities Review executed batch records and associated QC documentation for accuracy, completeness, and compliance with approved procedures. Support and ensure full traceability from raw materials through manufacturing execution and final product release. Oversee and/or support document control processes for Standard Operating Procedures (SOPs), batch records, forms, templates, and controlled records. Work with team to mature the Quality Management System (QMS). Analyze and document environmental monitoring data. Oversee corrective and preventive actions (CAPAs), laboratory investigations, and deviations related to bioprocessing, OOS/OOT results, equipment failures, environmental excursions, and documentation errors. Manage and approve change control requests related to materials, analytical methods, equipment, processes, or documents, ensuring all changes are risk-assessed and processed in accordance with the QMS. Assist in the qualification of new suppliers and vendors; review supplier documentation, audit reports, and ongoing performance evaluations. Serve as primary QA point of contact for contract suppliers and testing vendors, including drafting and maintaining Quality Agreements. Serve as primary QA point of contact for CDMO(s) and testing vendors, including review of batch records, quality agreements, and technical transfer documentation. Provide QA input and guidance on process changes, analytical strategies, equipment qualification, and operational risk mitigation. Support Clinical Operations and ensure GCP compliance through review of clinical documents, investigational product management, and site and vendor oversight. Oversee final disposition and release of Investigational Product (IP) for clinical use. Conduct internal and external GMP and GCP audits; maintain continuous inspection readiness for FDA and other regulatory authority inspections. Ensure all operational data (manufacturing, QC, analytical development, and clinical) comply with ALCOA+ data integrity principles. Identify and monitor data integrity risks and collaborate with IT and operational teams to strengthen controlled systems. Develop and deliver GMP and GCP training programs for manufacturing, QC, and clinical teams; ensure training records are complete and current. Support regulatory submissions (e.g., IND, IND Annual Reports) by providing QA-owned documentation, data, and certificates of analysis. Escalate quality issues promptly and clearly to senior management. Qualifications Bachelor’s degree in Life Sciences or a related scientific discipline required. Minimum of 3 years of experience in Quality Assurance within regulated biopharmaceutical, biotechnology, or pharmaceutical environments. Experience with cell therapy, gene therapy, or exosome/biologic modalities strongly preferred. Direct experience supporting GMP manufacturing and clinical-stage programs is highly desirable, including batch record review, deviation management, CAPA, change control, and document control. Strong understanding of data integrity principles (ALCOA+). Strong working knowledge of GMP, GCP, GLP, and FDA regulations. Experience with FDA inspections and regulatory audits strongly preferred. Excellent written and verbal communication skills. Ability to exercise sound judgment, maintain independence, and appropriately escal Ability to operate in a lean, cross-functional organization where this role may absorb responsibilities typically split across QA, QC, and Regulatory functions at larger companies. ASQ Certified Quality Auditor (CQA) or RAC certification a plus. Aruna Bio is an equal opportunity employer. #J-18808-Ljbffr

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