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 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
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
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
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
Experience with network-based applications such as Oracle, TrackWise , 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 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.
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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.
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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 [email protected]
