Manager GMP Quality Operations

The GMP Quality Operations Manager is recognized internally as an expert in the principles and application of quality assurance compliance and AI-enabled quality operations. The Quality Manager will provide QA supportofmanufacturing operations for the external manufacture of Cell & Genetic Therapeutic programs. This role will support activities related to product disposition including review of batch data batch records deviations in-process data EM data QC release testing and other quality systems documentation while advancing intelligent digitized solutions for backlog triage metrics generation records reconciliation and archiving to improve operational efficiency compliance and data integrity.

Key Duties & Responsibilities

• Responsible for quality support of Vertex Cell and Gene Therapy manufacturing operations across all phases of development support of analytical laboratory materialsmanagementand manufacturing operations.

• Support Quality System oversight across CDMOs focusing on compliance CAPA effectiveness change control and risk managementinaccordance withGxPand global quality standards

• Develop andmaintainquality metrics dashboards and reports in Python PowerBIand Smartsheet to provide clear visibility into QMSperformance and process trends

• Partner with External CDMOstoidentifyany operational efficiencies and drive implementation.

• Support audit andinspectionreadiness activities.

• Maintain periodic batch record metrics andassistsdepartment with routine/quarterly Quality System data review metrics and reporting

• Develop intelligent digitized solutions for archiving and lifecycle management of GMP records to improve retrieval traceability compliance and inspection readiness

• Develop AI-enabled catch-up solutions to support backlog triage prioritize quality records and accelerate resolution of deviations CAPAs and batch disposition activities to improve overall Quality operations

• Lead andparticipatein Cell & Genetic Program and Quality projects and drive continuous improvement activities.

• Implement AI-supported records reconciliation solutions toidentifydiscrepancies improve data integrity and enhance completeness and accuracy of GMP documentation across quality systems and manufacturing records

Required Knowledge/Skills

• Bachelors degreeinaBusiness/ Sciences field.

• QA experience in a GMP-regulated environment

• Demonstrated AI skills and digital capability to design and deliver intelligent solutions that improve Quality operations including backlog triage metrics generation records reconciliationand archiving within a GMP-regulated environment while supporting data integrity compliance and risk-based decision-making

• Demonstrated experience providing QA support to GMP manufacturing operation

• Experience with network-based applications such as OracleTrackWise Veeva

• Demonstrated high degree of expertise in using industry standard technology applications / programing techniques such as Python PowerBI and equivalent data organization and analytical tools.

• Ability to evaluate qualitymetrics strong problem solving and make decisionsutilizingrisk-based approach

• Proven experience leading a variety of projects/teams within statedobjectivesand timelines

• Ability to manage own workload to achieve goals and seek opportunities to share information and help others understand technical processes

• Proven experience in developing digitization solutions to improve efficiency and effectiveness of Quality GMP Operations.

• Strong communicationskills (written and verbal) with the ability to communicate effectively with cross functional team members exchanging complex information and influencing/guiding others to understand a stated viewpoint

The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors including skills competencies experience and other job-related factors permitted by law.

At Vertex our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career financial family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter) educational assistance programs including student loan repayment a generous commuting subsidy matching charitable donations 401(k) and so much more.