Sr. Manager, Quality Assurance for Quality Control

About the role

Genetix Biotherapeutics is pursuing curative gene therapies to give patients and their families more days. The Sr. Manager, Quality Assurance for Quality Control manages contract testing organizations (CTOs) for Quality Control activities supporting commercial operations.

This full-time position is based in the Somerville – Assembly Row, Massachusetts office and is hybrid, with three days a week in the office.

Responsibilities

• Manage CTOs for in-process and release testing of raw materials, starting materials, and drug products.
• Partner closely with CTOs and internal cross-functional teams, contributing to sample submission for release testing through Certificate of Analysis (COA) approval.
• Own and manage quality systems, including deviations, change controls, laboratory investigations, and corrective and preventative actions (CAPAs).
• Facilitate internal and external meetings with CTO partners, including joint management forums and risk assessments supporting CTO-facing change management and regulatory filings.
• Manage the stability program for all three commercial products, including data management and regulatory support.
• Manage Quality Control-related communications within CTOs and contract manufacturing organizations (CMOs).

Key facts

• Full-time position with three days a week in the office.
• Manages CTOs for Quality Control in-process and release testing.
• Manages the stability program for all three commercial products.