Open to opportunities

Tomas Drayton

@tomasdrayton

Message

I lead data quality and data integrity for GMP-regulated organizations.

United States

Message

What I'm looking for

I’m looking to lead data quality and integrity programs in GMP/regulated environments—owning standards, validation workflows, and CAPA-driven improvements while partnering across QA, IT, and operations to strengthen audit readiness and decision-ready reporting.

I’m a Data Quality Lead with extensive experience improving data accuracy, system integrity, and compliance across GMP-regulated and enterprise environments. I establish data standards, strengthen data validation workflows, and drive root-cause investigations to improve reliability and audit outcomes. I’m especially focused on traceability controls, metadata governance, and scalable quality controls that support analytics, reporting, and operational decisions.

In my roles across Quality Assurance, QMS, and manufacturing documentation, I’ve led CAPA-driven remediation for data deviations, ensured readiness for internal and external audits, and improved controlled-document lifecycle processes through stronger version control and metadata accuracy. I also partner with technical and business teams to streamline data processes and documentation, aligning digital records with requirements such as 21 CFR 210/211 and internal data standards.

Experience

Work history, roles, and key accomplishments

Current

Quality Assurance Specialist II

Current

Immatics US, Inc.

Apr 2024 - Present (2 years 2 months)

Led improvements to data quality and data integrity controls within GMP quality systems, strengthening accuracy, consistency, and compliance across operational workflows. Performed root-cause analysis on data deviations and implemented CAPA actions to improve data reliability and audit readiness.

Data Integrity Data Validation GMP Documentation CAPA Management Root Cause Analysis Traceability Controls Audit Readiness

Quality Assurance Specialist I

Immatics US, Inc.

Jul 2023 - Apr 2024 (9 months)

Audited biopharmaceutical production data to improve completeness, accuracy, and adherence to data integrity principles. Investigated data anomalies via deviation/CAPA processes using 5-Whys and fishbone analysis and supported audit preparation by validating datasets and documentation libraries.

Data Auditing Data Governance CAPA Management Root Cause Analysis

Quality Management Systems Specialist I

Immatics US, Inc.

Mar 2023 - Jul 2023 (4 months)

Enhanced QMS data lifecycle processes by improving document structure, version control, and metadata accuracy for controlled documents and quality datasets. Supported change control impact assessments and delivered onboarding training focused on data accuracy and documentation standards.

Metadata Management Document Version Control Change Control Document Control Data Governance Training Development Audit Alignment

Manufacturing Document Specialist I

1VGXI

Oct 2021 - Mar 2023 (1 year 5 months)

Led data-driven investigations into GMP nonconformances to improve data traceability and implement preventive actions that strengthened system integrity. Managed data review and approval workflows for clinical product disposition and conducted quality audits for data completeness, metadata accuracy, and CAPA documentation.

Data Auditing CAPA

Accounts Payable Vendor Support

Champion X

Jul 2021 - Oct 2021 (3 months)

Validated financial and vendor records by reconciling discrepancies and updating digital repositories to support audit readiness. Used SAP ERP and OnBase to troubleshoot data errors and maintain integrity across interconnected systems.

Data Reconciliation SAP ERP Onbase Audit Readiness

Quality Assurance Consultant

Bristol Myers-Squibb

Mar 2020 - Jun 2021 (1 year 3 months)

Improved data accuracy within GMP documentation by resolving discrepancies, standardizing entries, and optimizing data workflows. Streamlined document control using Veeva to improve digital upload processes and support better audit outcomes through reduced investigation cycle times.

GMP Documentation Document Control Veeva Data Standardization Cross Functional Collaboration