Lead, QCTS Data Integrity & Computerized Systems

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.

• 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.

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

• 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, Smart Sheets).
• Excellent project management tools proficiency (MS Project, Smart Sheets).
• Excellent executive communication skills, both written and oral.

The annual salary range for this position is $110,000–$150,000.

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.

• 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.
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