Lead, QCTS Data Integrity & Computerized Systems

Genezen; Lexington (MA); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

Paid vacation days

401(k) with company match

Choice of healthcare plans

Paid sick time

Job summary

Genezen in Lexington, Massachusetts is seeking a Lead, Quality Control Technical Services (QCTS) to ensure data integrity and regulatory compliance for laboratory systems. This role requires strong expertise in 21 CFR Part 11 and GMP environments, along with 10+ years in IT systems validation and management.

The successful candidate will lead the implementation of QC systems, support audits, and contribute to procedural documentation. The position also offers comprehensive benefits, including 401(k) participation and multiple healthcare plans.

Qualifications

• 10+ years of experience in IT Systems/CSV and data integrity.
• Prior experience working in a CDMO environment.
• Subject matter expert in Good Documentation Practices (GDP).

Responsibilities

• Ensure QC laboratory systems comply with 21 CFR Part 11.
• Support audits and inspections as the Data Integrity SME.
• Lead authoring of QCTS procedures and validation protocols.

Skills

21 CFR Part 11 expertise

GMP experience

Computer systems validation

Data integrity practices

Project management

Excellent communication

Education

Degree in science-related field

Tools

MS Word

Excel

MS Project

SmartSheets

Job description

About Genezen

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.

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

• 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 Value‑Based Competencies

• C — Committed to Science: We are committed to scientific excellence, staying current with industry developments, making data‑driven decisions, and pursuing innovation to advance healthcare.
• U — Urgency in action for the patients: We operate with urgency and a commitment to delivering timely treatments to patients by accelerating our partners' programs.
• R — Resilience & Grit in operations: We are committed to overcoming challenges, learning from failures, and persistently striving for success.
• E — Execute with Excellence & Integrity: We are dedicated to delivering quality results and upholding ethical principals.
• S — Solutions 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, vested immediately.
• 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.