Manager GMP Quality Operations

Job Description 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 Pay Range: $118,400 - $177,600 Disclosure Statement: 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. Flex Designation: On-Site Designated Flex Eligibility Status: In this On-Site designated role, you will work five days per week on-site with ad hoc flexibility. Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time. #LI-Onsite Company Information Vertex is a global biotechnology company that invests in scientific innovation. 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. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at View email address on click.appcast.io Help Us Achieve Our Mission Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. The company has approved medicines that treat the underlying causes of multiple chronic, life-shortening genetic diseases — cystic fibrosis, sickle cell disease and transfusion-dependent beta thalassemia — and continues to advance clinical and research programs in these diseases. Vertex also has a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where it has deep insight into causal human biology, including APOL1-mediated kidney disease, acute and neuropathic pain, type 1 diabetes, myotonic dystrophy type 1 and alpha-1 antitrypsin deficiency . Founded in 1989 in Cambridge, Mass., Vertex's global headquarters is now located in Boston's Innovation District and its international headquarters is in London. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia, Latin America and the Middle East. Vertex is consistently recognized as one of the industry's top places to work, including 14 consecutive years on Science magazine's Top Employers list and one of Fortune’s 100 Best Companies to Work For. For company updates and to learn more about Vertex's history of innovation, visit or follow us on Facebook, Twitter/X , LinkedIn, YouTube and Instagram. The diversity and authenticity of our people is part of what makes Vertex unique, and we recognize that each employee brings diverse perspectives and strengths. By embracing those strengths and celebrating differences, we are fostering an inclusive culture where each of us can bring our authentic selves to work, inspire innovation together, and change people’s lives. Our vision is clear: to be the place where an authentic, diverse mix of talent want to come, to stay, and do their best work.