Quality Systems & Compliance Specialist at MBX Biosciences in Burlington, MA

Job description

Working with Us MBX Biosciences is a clinical-stage biopharmaceutical company headquartered in Carmel, Indiana, with a secondary office in Burlington, MA. Our mission is to transform the lives of people impacted by endocrine and metabolic disorders through our novel precision peptides. Leveraging our proprietary Precision Endocrine Peptides (PEPs)™ platform, we are pioneering technology designed to overcome key limitations of existing therapies and enhance efficacy, tolerability, safety and convenience. Our team is advancing a pipeline of novel candidates with clinically validated targets, established endpoints for regulatory approval, and strong market potential. Our pipeline includes canvuparatide (MBX 2109) for the treatment of chronic hypoparathyroidism, currently preparing for Phase 3 development, and a growing obesity portfolio that includes MBX 4291 in Phase 1 development, MBX 5765, a next-generation amycretin prodrug designed for once-monthly-dosing, as well as MBX 6180, a GLP/GIP/GCGR triple agonist prodrug for once monthly dosing; all of which optimize our PEP platform. If you’re passionate about advancing innovative treatments for patients and shaping the future of precision peptide therapeutics, this is your chance to make a real impact alongside a fast-paced, growing, mission-driven team. To learn more, visit our website mbxbio.com and follow us on LinkedIn . What You’ll Do MBX Biosciences is seeking a highly motivated Quality Systems & Compliance Specialist to 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. What You Bring 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 enhanc