Manager, Quality Assurance Operations

Summary

The ‘Manager, Quality Assurance Operations’ role is responsible for providing end-to-end quality oversight of Contract Manufacturing Organizations (CMOs) to ensure compliance with cGMP regulations, regulatory commitments, and Genetix quality standards. This role serves as a key quality partner to Manufacturing, MS&T, Quality Control, and Patient Supply. The role is expected to serve as a CMO Lead point-of-contact and primary quality interface with external partners, driving proactive risk management, and Deviation and Change Control lifecycle management. The position ensures effective quality oversight through structured governance forums, review and approval of quality systems, and continuous monitoring of performance metrics.

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.
• Lead 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.

Required Education, Experience, or Qualifications (or equivalent)

Education & Experience
• Bachelor’s degree in Life Sciences, Engineering, or related discipline (advanced degree preferred)
• 7+ 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, EMA, 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

Leadership & 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