Lead, QCTS Data Integrity & Computerized Systems

Job Description

Job Description

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

• Serve as the QCTS Data Integrity and Computerized System Validation SME, ensuring QC laboratory systems comply with 21 CFR part 11, EU Annex 11 and internal DI policies.
• Provide expertise and support for QC computerized systems, including instrument software, standalone analytical instruments, and data acquisition/processing tools, including Excel spreadsheets.
• Partner with QC labs leads, system owners, Validation, and IT to ensure robust lifecycle management of QC systems, including system qualification, validation, periodic review, and configuration controls.
• Responsible for overall lifecycle management of computer system validation activities in QC/GMP environment.
• Lead implementation of change management of QC instruments, software upgrades, and new laboratory technologies to ensure readiness for GMP use.
• Maintain and improve data integrity practices within the QC function, including data review workflows, audit trails, user access, data storage, and backup/restore procedures.
• Support QC investigations (deviations, OOS/OOT, CAPAs) involving data integrity, system performance, or data workflow failures; provide technical root-cause contributions.
• Lead authoring and maintenance of QCTS procedures, work instructions, validation protocol, validation summary reports, and guidance documents relating to computerized systems, instrument qualification (IOQ, PQ), and data integrity.
• Coordinate with external qualified service providers to ensure QC systems are validated.
• Support internal and external audits/inspections as the QCTS Data Integrity SME, providing evidence for QC systems, validation documentation, and data governance controls.
• Deliver training, guidance, and technical mentorship to QC analysts and system users to strengthen data integrity awareness and consistent system usage across QC.

SPECIAL JOB REQUIREMENTS

• Adaptability required as work schedule may change based on business needs
• Criminal background check required
• Other duties as assigned

KNOWLEDGE, SKILLS AND EXPERIENCE

EDUCATION / CERTIFICATIONS / LICENSES

Degree in science-related field

ON-THE-JOB EXPERIENCE

10+ years of experience in IT Systems/CSV, Enterprise Solutions (Veeva, CDS), QMS (electronic and paper), and data integrity, Excel spreadsheet validation

SKILLS / ABILITIES

Prior experience working in a CDMO environment

10+ years working in a Good Manufacturing Practices (GMP) environment

Subject matter expert in 21 CFR Part 11, GAMP 5, EU Annex 11

Subject matter expert in Good Documentation Practices (GDP)

Excellent computer literacy (MS Word, Excel, SmartSheets)

Excellent project management tools (MS project, SmartSheets)

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

• Regularly sit for long periods of time

Movement

• Frequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and arms
• Occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl

Lifting

• Frequently lift and/or move up to 10 pounds
• Rarely lift and/or move up to 25 pounds

Vision

• Frequently utilize close vision and the ability to adjust focus

Communication

• Frequently required to communicate by talking, hearing, using telephone and e-mail

GENEZEN'S CURES VALUE-BASED COMPETENCIES

C ommitted to Science
We are committed to scientific excellence, staying current with industry developments, making data-driven decisions, and pursuing innovation to advance healthcare.

U rgency in action for the patients
We operate with urgency and a commitment to delivering timely treatments to patients by accelerating our partners' programs.

R esilience & Grit in operations
We are committed to overcoming challenges, learning from failures, and persistently striving for success.

E xecute with Excellence & Integrity
We are dedicated to delivering quality results and upholding ethical principals.

S olutions driven for our partners
We are committed to being a proactive, collaborative, creative and open-minded partner.

GENEZEN'S BENEFITS

• Paid vacation days, amount based on tenure
• Paid sick time
• 10 observed holidays + 2 floating holiday + 1 volunteer day
• 401(k) plan with company match up to 6% of salary
• Share Appreciation Rights
• Choice of several healthcare plans
• FSA and HSA programs
• Dental & vision care
• Employer-paid basic term life/personal accident insurance
• Voluntary disability, universal life/personal accident insurance
• Accidental Death & Dismemberment (AD&D) Insurance

ADDITIONAL DETAILS

• Nothing in the job description for this role restricts management's right to assign or reassign duties and responsibilities to this job at any time.
• This position requires a criminal background check.
• Genezen is an Equal Opportunity Employer.
• Genezen participates in EVerify.
• Genezen is interested in every qualified candidate who is eligible to work in the United States; however, we are not able to sponsor visas.

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.