Sr. Manager, Quality Systems and Compliance Technology

About the role

At Avalo (ahh-vah'-low), we are 100% focused on developing treatments for immune-mediated inflammatory diseases with large unmet needs that affect millions worldwide. Our strategy is to develop medicines that target the IL-1β pathway, which is a central driver of the inflammatory process. We share a commitment to teamwork, passion for science, and dedication to patients suffering from acute and chronic inflammatory disorders. Our collective expertise in discovery, development, and regulatory approvals is evidenced in our strong individual track records of advancing multiple therapeutic programs to successful commercialization. Position Summary We are seeking a highly motivated and detail-oriented Senior Manager, Quality Systems & Compliance Technology, to lead and manage our electronic Quality Management System (eQMS). This role is critical to ensuring compliance with internal procedures and global regulatory requirements. This role will be responsible for building, maintaining, and continuously improving scalable, inspection-ready Quality Systems that support clinical development, CMC, regulatory, and external partner oversight in a fast-paced biotech environment. This position will serve as a cross-functional Quality Systems leader with responsibility for QMS governance, workflows, computer system validation, and vendor/system qualification. The role is intended for a candidate with demonstrated experience leading enterprise QMS platforms, validating regulated SaaS systems, supporting GxP compliance across GMP/GCP/GDP environments, and preparing organizations for regulatory inspections.

Responsibilities

• Provide strategic ownership and operational oversight of enterprise Quality Systems, including document control, training, quality events, CAPA, change control, deviations, complaints, audits, and related workflows.
• Establish and maintain Quality Systems governance frameworks, policies, SOPs, role structures, workflows, and process controls to ensure compliance with internal procedures and applicable regulatory expectations.
• Partner with QA, Clinical Operations, CMC, Regulatory Affairs, IT, and external partners to ensure Quality Systems are scalable, effective, inspection-ready, and aligned with business needs.
• Monitor Quality System performance, identify trends, and drive continuous improvement across quality processes and electronic workflows.
• Support management review through quality metrics, process health indicators, training compliance data, periodic review status, audit outcomes, and quality event trends.
• Lead administration, configuration, enhancement, and lifecycle management of eQMS platforms, including modules for documents, training, quality events, CAPA, change control, audits