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Lexington, Tennessee, United States
Onsite
Not Available
The field of gene therapy is growing rapidly and Genezen is here to meet the exacting needs of our clients. We provide process development, produce GMP viral vectors, and provide cell transduction for gene and cell therapy clinical trials and are proud to be a part of the process that leads to new cures.
WORKING AT GENEZEN
Many people have worked in environments where you feel like just another nameless part of an enormous machine. Genezen is different. We want our employees to be innovative, collaborative problem solvers who are dedicated to meeting the challenges of working at a fast-growing company. We are dedicated to empowering our employees to be their best and making Genezen a rewarding place to work. Every employee contributes to the success of the company and you can be part of that team.
JOB SUMMARY
The Lead, Quality Control Technical Services (QCTS) – Data Integrity is responsible for ensuring that QC laboratory systems, instruments, software, and associated data workflows meet regulatory expectations for data integrity and GxP compliance. This role provides expert oversight and support across QC laboratory for computerized system implementation, instrument qualification, assay data workflows, software validation, and data governance activities. The lead partners closely with QC operations, Validation, IT, and system owners to ensure that QC systems are designed and maintained, and monitored in alignment with 21 CFR Part 11 and EU Annex 11, ALCOA+ principles, and corporate data integrity standards. The role supports audits and inspections, authors technical documentation, resolves data-related issues, and contributes leadership through scientific and systems expertise.
ESSENTIAL JOB FUNCTIONS
SPECIAL JOB REQUIREMENTS
KNOWLEDGE, SKILLS AND EXPERIENCE
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EDUCATION / CERTIFICATIONS / LICENSES |
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Degree in science-related field |
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ON-THE-JOB EXPERIENCE |
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10+ years of experience in IT Systems/CSV, Enterprise Solutions (Veeva, CDS), QMS (electronic and paper), and data integrity, Excel spreadsheet validation |
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SKILLS / ABILITIES |
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Prior experience working in a CDMO environment |
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10+ years working in a Good Manufacturing Practices (GMP) environment |
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Subject matter expert in 21 CFR Part 11, GAMP 5, EU Annex 11 |
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Subject matter expert in Good Documentation Practices (GDP) |
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Excellent computer literacy (MS Word, Excel, SmartSheets) |
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Excellent project management tools (MS project, SmartSheets) |
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Excellent executive communication skills, both written and oral |
Pay Range:
The annual salary range for this position is $110,000-$150,000.
PHYSICAL DEMANDS
While performing the duties of this job, the employee is required to meet the following physical demands:
Work Environment
Movement
Lifting
Vision
Communication
GENEZEN'S CURES VALUE-BASED COMPETENCIES
Committed to Science
We are committed to scientific excellence, staying current with industry developments, making data-driven decisions, and pursuing innovation to advance healthcare.
Urgency in action for the patients
We operate with urgency and a commitment to delivering timely treatments to patients by accelerating our partners' programs.
Resilience & Grit in operations
We are committed to overcoming challenges, learning from failures, and persistently striving for success.
Execute with Excellence & Integrity
We are dedicated to delivering quality results and upholding ethical principals.
Solutions driven for our partners
We are committed to being a proactive, collaborative, creative and open-minded partner.
GENEZEN'S BENEFITS
ADDITIONAL DETAILS
Genezen has operates two locations: one in Fishers, Indiana and the second in Lexington, Massachusetts.
Fishers is a suburb of Indianapolis. Fishers was named the #1 place to live in the US by Money Magazine in 2017 for its livability, safety and entrepreneurship. Fishers is one of the fastest growing communities in Indiana and is dedicated to supporting a high quality of life for all its residents. Nearby Indianapolis is home to professional and college sports teams, the Indy 500, a growing art community and the world’s largest children’s museum--to name just a few reasons why this area is a great place to live.
Lexington, Massachusetts, located just northwest of Boston, is renowned as a historic suburb with a rich cultural heritage. It boasts picturesque New England charm, tree-lined streets, and a vibrant community. Known for its pivotal role in the American Revolution, Lexington offers visitors and residents alike a blend of historical landmarks, modern amenities, and a strong sense of community pride.