Associate Manager, Quality Assurance Operations

This is a full-time hybrid position (3 days a week) in our Somerville – Assembly Row, Massachusetts office.

 Position Description:

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.

Job Duties and 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.

Essential/Required Qualifications

Education & Experience

• Bachelor’s degree in Life Sciences, Engineering, or related discipline (advanced degree preferred)
• 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

 Technical Skills

• Deep knowledge of cGMP regulations (FDA, ICH guidelines)
• Deviation, CAPA, and investigation processes
• Change Control systems and validation lifecycle
• Knowledge of lentiviral vector process preferred
• Knowledge of process validation preferred
• Strong understanding of cell/gene therapy manufacturing or biologics

 Core Competencies

• 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

Key Success Factors 

• Proactive risk identification and escalation during manufacturing operations
• Timely closure and high-quality management of deviations and investigations
• Strong, compliant oversight of CMO operations and quality systems
• Effective cross-functional collaboration and governance leadership
• Continuous improvement of quality systems and performance metrics

Additional Information

• Hybrid schedule based at the company's Somerville, Massachusetts headquarters, with on-site presence expected (three) days per week
• On-call QA support for manufacturing operations
• Prolonged periods of computer-based work.
• Occasional travel
• This position has no direct reports