Quality Systems & Compliance Specialist

MBX Biosciences, Inc.; Burlington (MA); Hybrid; USD 110,000 - 150,000; Full time

Job summary

MBX Biosciences, Inc. is seeking a Quality Systems & Compliance Specialist to oversee and enhance the Quality Management System, including document control, GxP training, and service provider lifecycle management.

The role ensures regulatory compliance and supports inspections across the organization. The ideal candidate will be detail‑oriented, collaborative, and experienced in regulated biotech environments, with strong organizational and communication skills and a proactive problem‑solver

Qualifications

• Bachelor's degree in a scientific, technical, or related discipline.
• Minimum of 4 years of experience in biotechnology, pharmaceutical, medical device, or other regulated industries.
• Experience managing quality system processes and supporting quality programs.

Responsibilities

• Own and maintain Document Control and GxP Training programs.
• Oversee Service Provider Lifecycle Management and related records.
• Develop and approve quality system procedures and controlled documents.
• Ensure compliance with GMP/GLP/GCP and global regulatory requirements.
• Support internal audits, inspections, and inspection readiness activities.

Education

Bachelor's degree in a scientific/technical discipline

Tools

eQMS

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 ofprecision peptide therapeutics, this is your chance to make a real impact alongside a fast‑paced, growing, mission-driventeam. 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 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.

EEO Statement

MBX Biosciences is an Equal Opportunity Employer and is committed to treating all applicants fairly without discrimination. We welcome applications from all individuals, regardless of race, national origin, gender, age, physical characteristics, social origin, disability, union membership, religion, family status, pregnancy, sexual orientation, gender identity, gender expression or any unlawful criterion under applicable law.