Manager, Quality Assurance Operations

Manager, Quality Assurance OperationsThe '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.This is a full-time hybrid position (3 days a week) in our Somerville – Assembly Row, Massachusetts office.ResponsibilitiesProvide on-call QA support for manufacturing operations, ensuring proactive identification, escalation, and mitigation of quality events and risks impacting ongoing manufacturing and product dispositionMaintain 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 ControlsServe 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 deliverablesMonitor 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 & ExperienceBachelor'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 manufacturingStrong experience supporting CMO oversight and external manufacturing environmentsTechnical SkillsDeep knowledge of: cGMP regulations (FDA, EMA, ICH guidelines), Deviation, CAPA, and investigation processes, Change Control systems and validation lifecycleKnowledge of lentiviral vector process preferredKnowledge of process validation preferredStrong understanding of cell/gene therapy manufacturing or biologicsLeadership & CompetenciesDemonstrated ability to lead cross-functional quality governance forumsStrong risk-based decision-making and escalation capabilitiesExcellent communication, stakeholder management, and influential skills in internal and external settingsAbility to operate effectively in a fast-paced, matrixed CMO environmentHigh attention to detail with an inspection-ready mindsetKey Success FactorsProactive risk identification and escalation during manufacturing operationsTimely closure and high-quality management of deviations and investigationsStrong, compliant oversight of CMO operations and quality systemsEffective cross-functional collaboration and governance leadershipContinuous improvement of quality systems and performance metricsPay Transparency$118,000 - $166,000 USDGenetix is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status or any other applicable legally protected characteristics.