QA Oversight Director: QC & CTO Compliance

MBX Biosciences, Inc.; United States; Hybrid; USD 140,000 - 200,000; Full time

Job summary

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

Responsibilities

• 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.

Skills

Regulatory knowledge

Vendor management

cGMP regulations

Analytical methods

LIMS/Empower

Education

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

Tools

HPLC

GC

Mass spectrometry

LIMS

Empower

Job description

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.