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 - $177,600Disclosure 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 DesignatedFlex 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 [email protected]
Skills Required
- Bachelor's degree in a Business or Sciences field
- 5+ years of QA experience in a GMP-regulated environment
- Hands-on experience with ATMPs (cell therapy, gene therapy, tissue-engineered products) or Biologicals/sterile processes
- Demonstrated AI skills and digital capability to design and deliver intelligent quality operations solutions
- Experience providing QA support to GMP manufacturing operations
- Experience with network-based applications such as Oracle, TrackWise, Veeva
- Ability to evaluate quality metrics, apply risk-based decision making, and strong problem solving skills
- Proven experience leading projects and teams to meet objectives and timelines
- Ability to manage workload independently and support cross-functional teams
- Strong written and verbal communication skills to influence cross-functional stakeholders
Vertex Pharmaceuticals Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Vertex Pharmaceuticals and has not been reviewed or approved by Vertex Pharmaceuticals.
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Parental & Family Support — Policies provide 12 weeks of 100% paid bonding leave for all U.S. parents with additional fully paid time for birth parents. Family-forming supports include adoption and surrogacy assistance, fertility options like IVF and egg cryopreservation, breast‑milk shipping, subsidized childcare, backup care, and a DCFSA match.
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Leave & Time Off Breadth — Time off includes roughly four weeks of vacation, 13 holidays, sick time, and two companywide shutdowns (summer and year‑end). Some roles also include flexible or unlimited time off and paid volunteer time.
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Retirement Support — Programs include a 401(k) plan with employer contributions and an employee stock purchase plan. Filings describe employer contributions occurring in company stock, supporting long‑term ownership.
Vertex Pharmaceuticals Insights
What We Do
Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious and life-threatening diseases. We discovered and developed the first medicines to treat the underlying cause of cystic fibrosis (CF), a rare, life-threatening genetic disease. In addition to clinical development programs in CF, Vertex has more than a dozen ongoing research programs focused on the underlying mechanisms of other serious diseases. Founded in 1989 in Cambridge, Massachusetts, our corporate headquarters is now located in Boston’s Innovation District, and our international headquarters is in London, United Kingdom. We currently employ approximately 3,500 people in the United States, Europe, Canada, Australia and Latin America with nearly two-thirds of our staff dedicated to research and development. Vertex is consistently recognized as one of the industry’s top places to work by Science Magazine, The Boston Globe, Boston Business Journal and the San Diego Business Journal. Our research and medicines have also received esteemed recognitions, including the Robert J. Beall Therapeutics Development Award, the French Prix Galien and the British Pharmacological Society awards.
