New · posted Oct 15
MBX Biosciences · Biotechnology
Quality Systems & Compliance Specialist
- Burlington, MA
- Hybrid
- Full-time
- Associate & Specialist
Open until filled
The role
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 need
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 Qualificationsnice to have
- 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.
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.
Where you'll work
Burlington, MAHybridOpen in Maps (opens in a new tab)
More jobs in Burlington, MAWorking conditions
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.
Equal opportunity, accessibility and legal noticesMBX Biosciences's statements, word for word
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.
Job intelligence
The context around this role
Live data · October 15, 2026
Salary intelligence
How the pay compares
Associate & Specialist roles in the US157 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| All US (middle half) | $59,000 | $78,500 | $94,000 |
Comparisons: the base pay employers published on open Quality Assurance roles at the same level on Regulatory Jobs, October 15, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Assurance
The general path across 845 open Quality Assurance roles on Regulatory Jobs, with the titles they carry most. Not MBX Biosciences's own promotion track.
Career resources on Quality Assurance
Skills DNA
What this role leans on
How many of the posting's 28 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Quality systems and risk10
- GMP and compliance9
- Collaboration and leadership8
- Documentation and SOPs6
- Validation and qualification3
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- FDA21 CFR Parts 210 and 211(official source, opens in a new tab)FDA current good manufacturing practice for finished pharmaceuticals
- FDA21 CFR Part 58 (GLP)(official source, opens in a new tab)Good laboratory practice for nonclinical laboratory studies
- ICHICH E6 good clinical practice(official source, opens in a new tab)The international standard for the conduct of clinical trials
From Regulatory News
Manufacturing and quality coverage for this professionCompany hiring pulse
MBX Biosciences on Regulatory Jobs
- 2
- Open roles
- 2
- Distinct roles
- 1
- Locations
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Quality Systems & Compliance Specialist at MBX Biosciences
Open until filled.