New · posted Oct 17
MBX Biosciences · Biotechnology
Associate Director, QA Oversight for QC
- Burlington, MA
- Hybrid
- Full-time
- Director
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 or Master’s degree in chemistry, Microbiology, pharmacy, or a related scientific discipline
- 8+ years of experience in the pharma/biotech industry, including a strong blend of internal QA/QC experience and direct external vendor management (CMO/CTO oversight).
- Regulatory & Vendor Management Knowledge
- Deep knowledge of global cGMP regulations (21 CFR Parts 210/211/11, EU Annex 11) and standard practices for outsourcing pharmaceutical testing
- Strong technical understanding of advanced analytical methodologies (HPLC/GC, mass spectrometry, cell culture assay) and electronic laboratory systems (LIMS, Empower)
- Proven track record of managing external partnerships, cross-functional collaboration, and the ability to influence compliance cultures at third-party organizations.
What you'll do
The Associate Director of QA Oversight for QC and CTO provides strategic leadership and independent compliance oversight for all internal Quality Control (QC) operations and external Contract Testing Organizations (CTOs). This role ensures that all product testing, stability programs, and environmental monitoring workflows—whether executed in-house or by third-party vendors—strictly adhere to cGMP, data integrity regulations, and global health authority expectations. The Associate Director manages vendor quality agreements, drives external investigation closures, and acts as the ultimate authority on the compliance of data used for product release.
Key Responsibilities Include:
- External Lab (CTO) Governance: Establish, maintain, and execute the QA oversight strategy for all approved Contract Testing Organizations (CTOs). Serve as the primary QA point of contact for external testing escalations.
- Vendor Audits & Qualification: Lead or oversee routine qualification and for-cause compliance audits of CTO facilities. Ensure external labs maintain robust systems for data backup, instrument calibration, and analyst training.
- Quality Agreements: Negotiate, author, and maintain Quality Agreements with CTOs to ensure clear alignment on roles, testing timelines, data transfer protocols, and regulatory expectations.
- External Deviation & OOS Management: Provide QA oversight and approval for Out-of-Specification (OOS) results, Out-of-Trend (OOT) data, and laboratory deviations originating at CTO sites. Ensure external root cause investigations are scientifically rigorous.
- Data Integrity Governance: Serve as the authority for data integrity (ALCOA+ principles) across both internal QC systems and external CTO workflows. Verify that third-party labs utilize compliant audit trails and electronic data lifecycle management
- Tech Transfer & Validation Review: Provide high-level QA sign-off on analytical method transfer protocols, co-validations, and method verification studies between internal sites and external CTOs.
- Inspection Readiness & Leadership: Lead regulatory inspection preparation for the internal QC footprint and support CTO sites during health authority audits that involve the company's products.
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 20, 2026
Salary intelligence
How the pay compares
Director roles in Massachusetts33 roles publishing pay
Director roles in the US104 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| Massachusetts (middle half) | $186,000 | $200,000 | $231,000 |
| All US (middle half) | $186,000 | $209,250 | $232,625 |
Comparisons: the base pay employers published on open Quality Assurance roles at the same level on Regulatory Jobs, October 20, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Assurance
The general path across 895 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 19 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Lab testing and methods9
- GMP and compliance7
- Collaboration and leadership6
- Data and digital systems4
- Validation and qualification3
- Investigations and CAPA2
- Regulatory submissions2
- Documentation and SOPs1
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
- FDAFDA data integrity guidance(official source, opens in a new tab)Data Integrity and Compliance With Drug CGMP: Questions and Answers
- FDAFDA OOS guidance(official source, opens in a new tab)Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production
- FDA21 CFR Part 58 (GLP)(official source, opens in a new tab)Good laboratory practice for nonclinical laboratory studies
- ICHICH quality guidelines(official source, opens in a new tab)Q1 stability, Q2(R2) analytical validation, Q7, Q9 risk management, Q10 quality systems
- European CommissionEU GMP (EudraLex Volume 4)(official source, opens in a new tab)The EU's good manufacturing practice rules and annexes
Company hiring pulse
MBX Biosciences on Regulatory Jobs
- 3
- Open roles
- 3
- Distinct roles
- 1
- Locations
By discipline
- Quality2 67%
- Regulatory1 33%
By level
- Associate & Specialist2 67%
- Director1 33%
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Associate Director, QA Oversight for QC at MBX Biosciences
Open until filled.