MBX Biosciences is seeking a highly motivated Quality Systems & Compliance Specialistto oversee and continuously enhance key elements of the Quality Management System (QMS), including Document Control, GxP Training, and Service Provider Lifecycle Management. This individual will play a critical role in ensuring compliance with applicable regulatory requirements, supporting inspection readiness activities, and partnering cross-functionally to maintain effective and sustainable quality processes across the organization. The ideal candidate is detail-oriented, collaborative, and experienced in quality system management within a regulated biotechnology or pharmaceutical environment. • Own and maintain the Document Control and GxP Training programs. • Manage document review, approval, issuance, revision, periodic review, and archival processes. • Oversee training curricula, assignments, compliance monitoring, and training effectiveness. • Provide oversight for Service Provider Lifecycle Management. • Support service provider qualification, approval, monitoring, and requalification activities. • Maintain the Approved Service Provider List, annual audit schedule, and supporting records. • Develop, revise, review, and approve quality system procedures and controlled documents. • Ensure assigned quality systems comply with applicable GxP regulations and company procedures. • Monitor quality system metrics and identify process improvement opportunities. • Support eQMS administration for assigned processes. • Support internal audits, inspections, and inspection readiness activities. • Assess regulatory changes and implement required updates. • Provide training and guidance on assigned quality system processes. Bachelor's degree in a scientific, technical, or related discipline. Minimum of 4 years of experience within biotechnology, pharmaceutical, medical device, or other regulated industries. Minimum of 3 years of experience managing quality system processes. Experience supporting Document Control, GxP Training, and/or Service Provider Quality programs. Experience working with electronic Quality Management Systems (eQMS). Strong knowledge of GMP, GLP, GCP, and applicable global regulatory requirements. Experience supporting regulatory inspections, audits, and inspection readiness programs. Excellent organizational, communication, and problem-solving skills. Strong attention to detail and ability to manage multiple priorities in a fast-paced environment. Preferred Qualifications Experience in a clinical-stage biotechnology company. Experience implementing or enhancing quality systems and process improvements. Experience with supplier and service provider qualification and oversight programs. Working knowledge of risk-based quality management principles. Travel & In Office Presence You will be expected to travel periodically based on the needs of the business, including attendance at Together Weeks, Together Days, and functional meetings as requested by the team. Employees are expected to work on hybrid schedules, consistent with local office practices and the terms of the companies in office policy as in effect from time to time.