QA Oversight Director, QC & External Labs

MBX Biosciences, Inc.; Burlington (MA); Hybrid; USD 180,000 - 240,000; Full time

Job summary

MBX Biosciences, Inc. is seeking an Associate Director of QA Oversight for QC and CTO to lead strategic QA programs and ensure compliant testing across internal and external labs. This role focuses on cGMP adherence, data integrity, and vendor management to support product release.

You will drive QA governance with CTOs, oversee audits, and ensure alignment on quality agreements and regulatory expectations while leading inspection readiness and cross-functional collaboration.

Qualifications

• 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.

Responsibilities

• 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.
• 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.
• Negotiate, author, and maintain Quality Agreements with CTOs to ensure clear alignment on roles, testing timelines, data transfer protocols, and regulatory expectations.
• 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.
• 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
• Provide high-level QA sign-off on analytical method transfer protocols, co-validations, and method verification studies between internal sites and external CTOs.
• Lead regulatory inspection preparation for the internal QC footprint and support CTO sites during health authority audits that involve the company’s products.

Skills

QA/QC Oversight

Vendor management

Regulatory knowledge

cGMP

Data integrity

Education

Bachelor’s or Master’s degree in chemistry, Microbiology, pharmacy, or related

Tools

LIMS

Empower

HPLC

GC

Mass spectrometry

Job description

MBX Biosciences, Inc. is seeking an Associate Director of QA Oversight for QC and CTO to lead strategic QA programs and ensure compliant testing across internal and external labs. This role focuses on cGMP adherence, data integrity, and vendor management to support product release.

You will drive QA governance with CTOs, oversee audits, and ensure alignment on quality agreements and regulatory expectations while leading inspection readiness and cross-functional collaboration.