Lead, QCTS Data Integrity & Computerized Systems

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

Benefits offered by this job

Paid vacation days

401(k) plan with company match

Choice of healthcare plans

Paid sick time

Job summary

Dormont Manufacturing Co is seeking a Lead, Quality Control Technical Services to ensure QC laboratory systems meet regulatory expectations and GxP compliance. The role involves oversight of computerized systems and support for audits and technical documentation.

Ideal candidates will have over 10 years of experience in relevant fields, along with a degree in a science-related discipline. Competitive salary range of $110,000–$150,000.

Qualifications

• 10+ years of experience in IT systems/CSV and data integrity.
• Subject-matter expert in 21 CFR Part 11 and GAMP 5.
• Prior experience in a CDMO environment.

Responsibilities

• Ensure QC laboratory systems comply with regulatory standards.
• Provide support for audits and inspections.
• Lead authoring and maintenance of procedures and protocols.

Skills

IT systems/CSV

Data integrity

Excellent communication skills

Project management tools proficiency

Computer literacy

Education

Degree in a science-related field

Tools

Excel

SmartSheets

MS Project

Job description

Job Summary

The Lead, Quality Control Technical Services (QCTS) – Data Integrity ensures that QC laboratory systems, instruments, software, and associated data workflows meet regulatory expectations for data integrity and GxP compliance. This role provides oversight and support across the 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 QC systems are designed and maintained in alignment with 21 CFR Part 11, EU Annex 11, ALCOA+ principles, and corporate data integrity standards.

Key responsibilities include supporting audits and inspections, authoring technical documentation, resolving data‑related issues, and providing 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 such as Excel spreadsheets.
• Partner with QC labs leads, system owners, Validation, and IT to ensure robust lifecycle management of QC systems, including qualification, validation, periodic review, and configuration controls.
• Lead implementation of change management for QC instruments, software upgrades, and new laboratory technologies to ensure GMP readiness.
• 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 protocols, validation summary reports, and guidance documents related to computerized systems and instrument qualification.
• 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

• Degree in a science‑related field.
• 10+ years of experience in IT systems/CSV, enterprise solutions (Veeva, CDS), QMS (electronic and paper), and data integrity, Excel spreadsheet validation.
• Prior experience working in a CDMO environment.
• 10+ years working in a 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 proficiency (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.

Benefits

• Paid vacation days, amount based on tenure.
• Paid sick time.
• 10 observed holidays, 2 floating holidays, and 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 and 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.

Locations

Fishers, Indiana and Lexington, Massachusetts.

EEO Statement

Genezen is an Equal Opportunity Employer. Genezen participates in EVerify and does not sponsor visas for non‑U.S. citizens.