Associate Director, QA Oversight for QC

MBX Biosciences • Burlington, MA

23d • Hybrid

About The Position

The Associate Director of QA Oversight for QC and CTO provides strategic leadership and independent compliance oversight for internal Quality Control (QC) operations and external Contract Testing Organizations (CTOs). The role ensures product testing, stability programs, and environmental monitoring workflows performed internally or by third-party vendors comply with cGMP, data integrity regulations, and global health authority expectations. The Associate Director manages vendor quality agreements, drives external investigation closures, and serves as the ultimate authority on the compliance of data used for product release.

The role leads QA oversight of approved CTOs, vendor qualification and audits, quality agreements, external deviation and OOS/OOT management, and data integrity governance across internal QC systems and external workflows. It also provides QA review and sign-off for analytical method transfers and validations, leads regulatory inspection preparation for the internal QC footprint, and supports CTO sites during relevant health authority audits.

Periodic business travel is expected, including attendance at Together Weeks, Together Days, and functional meetings as requested. Employees work hybrid schedules consistent with local office practices and the company's in-office policy.

Requirements

• Bachelor’s or Master’s degree in chemistry, microbiology, pharmacy, or a related scientific discipline.
• At least 8 years of experience in the pharma/biotech industry, including internal QA/QC experience and direct external vendor management (CMO/CTO oversight).
• Deep knowledge of global cGMP regulations, including 21 CFR Parts 210/211/11 and EU Annex 11, and standard practices for outsourcing pharmaceutical testing.
• Strong technical understanding of advanced analytical methodologies, including HPLC/GC, mass spectrometry, and cell culture assay.
• Strong technical understanding of electronic laboratory systems, including LIMS and Empower.
• Proven track record managing external partnerships and cross-functional collaboration, with the ability to influence compliance cultures at third-party organizations.

Responsibilities

• Establish, maintain, and execute the QA oversight strategy for approved Contract Testing Organizations (CTOs), and serve as the primary QA contact for external testing escalations.
• Lead or oversee routine qualification and for-cause compliance audits of CTO facilities.
• Ensure external laboratories maintain robust systems for data backup, instrument calibration, and analyst training.
• Negotiate, author, and maintain Quality Agreements with CTOs covering roles, testing timelines, data transfer protocols, and regulatory expectations.
• Provide QA oversight and approval for OOS results, OOT data, and laboratory deviations originating at CTO sites, ensuring root cause investigations are scientifically rigorous.
• Govern data integrity in internal QC systems and external CTO workflows, including verifying 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 involving the company's products.
• Travel periodically based on business needs, including attending Together Weeks, Together Days, and functional meetings as requested.

What This Job Offers

• Job Type: Full-time
• Career Level: Director