Associate Manager, Quality Assurance Operations

The role

The Associate Manager, Quality Assurance Operations provides quality oversight of external manufacturing partners to ensure compliance with cGMP requirements and Genetix quality standards. This role serves as a quality liaison across internal teams and CMOs to support risk management, deviations, and change control activities.

What you will do

• Provide on-call QA support for manufacturing operations
• Maintain an external oversight model and lead QA-to-QA forums
• Support internal Deviation/Lab Investigation Management meetings
• Review and Approve internal and external CMO Deviations and Change Controls
• Serve as QA point-of-contact for Product Complaints
• Perform Quality Impact Assessments for Change Controls
• Represent Quality Assurance Operations in Manufacturing Tier and CCRB meetings
• Serve as QA reviewer and approver for validation protocols, reports, and technical documentation
• Monitor CMO quality performance metrics and drive continuous improvement
• Own and manage CMO Quality Agreements

Required qualifications

• 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
• Strong understanding of cell/gene therapy manufacturing or biologics
• Demonstrated ability to lead cross-functional quality governance forums
• Strong risk-based decision-making and escalation capabilities
• Excellent communication, stakeholder management, and influential skills
• Ability to operate effectively in a fast-paced, matrixed CMO environment
• High attention to detail with an inspection-ready mindset

Nice to have

• advanced degree
• Knowledge of lentiviral vector process
• Knowledge of process validation

Benefits

• comprehensive health, life and disability insurance
• employer-matched 401(k) plan
• lifestyle spending account
• flexible time-off
• paid holidays
• winter holiday period
• tuition reimbursement & loan repayment assistance
• paid parental leave
• paid onsite parking
• commuter subsidy

About the company

Genetix Biotherapeutics is pursuing curative gene therapies. The company values innovation through diversity and cooperation.