Associate Manager, Quality Assurance Operations

Genetix Biotherapeutics•Somerville, MA

10d•Hybrid

About The Position

The Associate Manager, Quality Assurance Operations will provide quality oversight of external manufacturing partners to ensure compliance with cGMP requirements, regulatory commitments, and Genetix quality standards. This role will serve as a key quality liaison across internal teams (Manufacturing, MS&T, Quality Control, and Patient Supply) and CMOs, supporting risk management, deviation and change control activities, quality system review, governance forums, and performance monitoring to drive consistent, compliant, and effective operations.

Requirements

Bachelor’s degree in Life Sciences, Engineering, or related discipline
4-6 years of experience in Quality Assurance within GMP-regulated biopharmaceutical or cell/gene therapy manufacturing
Strong experience supporting CMO oversight and external manufacturing environments
Deep knowledge of cGMP regulations (FDA, ICH guidelines)
Deviation, CAPA, and investigation processes
Change Control systems and validation lifecycle
Demonstrated ability to lead cross-functional quality governance forums
Strong risk-based decision-making and escalation capabilities
Excellent communication, stakeholder management, and influential skills in internal and external settings
Ability to operate effectively in a fast-paced, matrixed CMO environment
High attention to detail with an inspection-ready mindset

Nice To Haves

advanced degree preferred
Knowledge of lentiviral vector process preferred
Knowledge of process validation preferred
Strong understanding of cell/gene therapy manufacturing or biologics

Responsibilities

Provide on-call QA support for manufacturing operations, ensuring proactive identification, escalation, and mitigation of quality events and risks impacting ongoing manufacturing and product disposition
Maintain a consistent and effective external oversight model, including leading QA-to-QA forums and guiding quality discussions in joint governance meetings with CMOs.
Support regular internal Deviation/Lab Investigation Management meetings, ensuring compliance, quality, and timeliness.
Review and Approve internal and external CMO Deviations and Change Controls
Serve as QA point-of-contact for Product Complaints, ensuring appropriate investigation, documentation, and closure.
Perform Quality Impact Assessments for Change Controls, ensuring appropriate risk evaluation and mitigation.
Represent Quality Assurance Operations in Manufacturing Tier meetings, ensuring alignment on quality risks, priorities, and escalation pathways.
Represent Quality Assurance Operations in Change Control Review Board (CCRB) meetings.
Serve as QA reviewer and approver for: process validation protocols and reports, technical reports and supporting documentation, and internal and external validation deliverables
Monitor CMO quality performance metrics, identify trends, and drive continuous improvement initiatives.
Own and manage CMO Quality Agreements, including authoring, reviewing, negotiating, and maintaining compliance with current regulatory expectations.
Author and review Annual Product Quality Reviews (APQRs) to ensure comprehensive evaluation of product and process performance.
Identify trends, risks, and opportunities for improvement across the product lifecycle.