Associate Director, QA Oversight for QC

MBX Biosciences, Inc.; United States; Hybride; USD 140 000 - 200 000; Plein temps

Résumé du poste

MBX Biosciences, Inc. is seeking an Associate Director of QA Oversight for QC and CTO to provide strategic leadership ensuring cGMP compliance for internal testing and external contract labs. You will manage QA governance, vendor oversight, data integrity, and regulatory readiness across global operations.

Travel may be required; the role supports both in-house QC and external testing partners on a hybrid schedule. A strong background in analytical testing and regulatory compliance is essential.

Qualifications

• 8+ years of experience in pharma/biotech QA/QC and external vendor management
• Regulatory & vendor management knowledge demonstrated in external partnerships
• Deep knowledge of global cGMP regulations (21 CFR Parts 210/211/11, EU Annex 11) and outsourcing practices
• Strong technical understanding of analytical methodologies (HPLC/GC/mass spec) and electronic lab systems (LIMS, Empower)
• Proven track record of cross-functional collaboration and inspection readiness

Responsabilités

• External CTO governance and QA oversight strategy.
• Lead or oversee CTO audits and facility qualification.
• Negotiate and maintain Quality Agreements with CTOs.
• Oversee External Deviation/OOS management and investigations.
• Ensure data integrity across internal QC and CTO workflows (ALCOA+).
• Sign off on transfer protocols, co-validations, and method verifications.
• Lead regulatory inspection preparation for QC footprint and support CTO audits.

Connaissances

Regulatory knowledge

Vendor management

cGMP regulations

Analytical methods

LIMS/Empower

Formation

Bachelor's or Master's in chemistry/biomicro/pharmacy

Outils

HPLC

GC

Mass spectrometry

LIMS

Empower

Description du poste

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

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.

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.

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.