Manager GMP Quality Operations

Job Description GMP Quality Operations Manager is recognized as an internal 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 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 assist 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 operations. Experience with network-based applications such as Oracle, TrackWise, Veeva. Ability to evaluate quality metrics, strong problem solving and make decisions utilizing a 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 share information to 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. Equal Employment Opportunity Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. If you require an accommodation in connection with the hiring process or to perform the essential functions of the position, please contact the recruiter or hiring manager, or email View email address on click.appcast.io for assistance. #J-18808-Ljbffr Vertex Pharmaceuticals Incorporated