Genetix Biotherapeutics

Genetix Biotherapeutics

Manager, Quality Assurance Operations

Somerville, MA · Full-time

Sponsorship not specified$118k-$166kDetected 8 days ago
Product ManagementStakeholder ManagementControlsGMPFDA RegulatoryCRISPRLeadershipCommunicationCollaboration

About the role

  • This is personal and we approach every challenge with radical care.
  • The position ensures effective quality oversight through structured governance forums, review and approval of quality systems, and continuous monitoring of performance metrics.
  • This is a full-time hybrid position (3 days a week) in our Somerville - Assembly Row, Massachusetts office.

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.
  • Perform Quality Impact Assessments for Change Controls, ensuring appropriate risk evaluation and mitigation.
  • 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.

Nice to have

  • Identify trends, risks, and opportunities for improvement across the product lifecycle.
  • 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

Skills

  • 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

Compensation

  • $118,000 - $166,000 USD
  • The pay transparency range provided below is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting.
  • Author and review Annual Product Quality Reviews (APQRs) to ensure comprehensive evaluation of product and process performance.

Company info

  • Our innovation is rooted in the diversity of our teams and results are achieved through cooperation and the integration of multiple viewpoints.
  • 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.
  • About Genetix Biotherapeutics
  • At Genetix Biotherapeutics every role has meaning, every team member is respected, and every day is a chance to make a difference.
  • When you join Genetix, you're not just landing a new role, you become part of a company that's pursuing curative gene therapies to give patients and their families more days.

Equal opportunity

  • Genetix is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment.
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