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 support of manufacturing operations for the external manufacture of Cell & Genetic Therapeutic programs. This role will drive, review, and 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, materials management and manufacturing operations.  

• Support Quality System oversight across CDMOs, focusing on compliance, CAPA effectiveness, change control, and risk management in accordance with GxP and global quality standards 

• Develop and maintain quality metrics, dashboards, and reports in Python, Power BI and Smartsheet to provide clear visibility into QMS performance and process trends 

• Partner with External CDMOs to identify any operational efficiencies and drive implementation. 

•   Responsible for identifying compliance risks and gaps for GMP processes and supporting implementation of mitigating controls  

• Support audit and inspection readiness activities.  

• Maintain periodic batch record metrics and assists department 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 and participate in Cell & Genetic Program and Quality projects and drive continuous improvement activities.  

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

Required Knowledge/Skills  

• Bachelor's degree in a Business / Sciences field.  

• 5+ years of QA experience in a GMP-regulated environment  

• Hands-on experience with ATMPs (cell therapy, gene therapy, tissue-engineered products) strongly preferred or with Biologicals/sterile  

• Demonstrated AI skills and digital capability to design and deliver intelligent solutions that improve Quality operations, including backlog triage, metrics generation, records reconciliation, and 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 Oracle, TrackWise, Veeva  

• Ability to evaluate quality metrics, strong problem solving and make decisions utilizing risk-based approach  

• Proven experience leading a variety of projects/teams within stated objectives and timelines  

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

• Strong communication skills (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.