Company Overview RION is a clinical-stage biotechnology company based in Rochester, Minnesota. RION was founded as a Mayo Clinic Employee Entrepreneurial Program startup company. RION s mission is to develop clinically impactful and accessible therapies using innovative regenerative medicine technologies based on extracellular vesicle science. Our proprietary exosome platform has the ability to address significant unmet patient needs in many fields of medicine; accordingly, we are actively pursuing clinical programs in wound healing, cardiovascular diseases, and women s health. Our ultimate mission is to deliver cutting edge solutions accessible to any patient in need, anywhere in the world. Position Overview The QC Operation Lab Manager will lead and manage the GMP commissioning program of equipment and instruments used in Rion Tx. This role ensures the equipment and instruments within the QC are Qualified, Calibrated and Maintained according to the specified standards and procedures according to GMP compliance. This role will also support Computerized System Validation for QC and serves as administrator for user account maintenance. Key Responsibilities The primary responsibilities of this role are to: Leading the GMP commissioning and qualification process (IQOQPQ, data integrity and audit trails, tagging) by drafting and approving protocols/reports, coordinating cross functional activities (including vendors and contractors). Managing the lab s Calibration and Preventive Maintenance program by working with outside contractors. Providing guidance and direction to contractors to ensure compliance to procedures. Coordinating with equipment vendors when significant repairs are needed. Creating and maintaining the company s Calibration and PM program. Ensuring that Rion s policies, directives, and regulatory authority guidance (GMPs) are followed. Initiating equipment/instrument related complex deviations, CAPAs etc. and leading efforts to close out these events. Drafting complex SOPs, complex OIs and Best Practices and making sure they are aligned with Rion s base SOPs. Leading cross-functional activities (QA, technical operations) to develop Quality Assurance Agreements with various contractors and vendors. Prepare recommendations to management for future budgets / supporting capital equipment procurement, installation and documentation. Other roles and responsibilities assigned by QC management.