Open to opportunities

Omar Andrés González Gallegos

@omarandrsgonzlezgall

Message

I lead regional quality systems, compliance, audits, and data-driven optimization.

Mexico

Message

What I'm looking for

I'm looking to lead regional quality, compliance, QMS digitalization, audit readiness, and data-driven continuous improvement in highly regulated, cross-functional international environments.

At PerkinElmer, I led LATAM quality assurance work across Mexico, Argentina, and Chile, successfully defending more than 14 ISO 9001:2015 audits with 100% compliance and zero major non-conformances.

I've modernized QMS and document-control workflows through LMS, Docebo, OCARNOS, SAP, and SharePoint, while building Power BI dashboards that support executive decisions, project tracking, and continuous audit readiness. I also coordinated compliance and systems training for more than 400 professionals across the Americas and Europe.

My background spans quality assurance, regulatory affairs, analytical control, and laboratory leadership at Signa, Abbott Laboratories, Novartis, and Tecnofarma. I've led CAPA, deviation, OOS/OOE, and aberrant-result investigations, analytical method transfers, validation protocols, and lean laboratory initiatives.

I bring 19 years of international experience in regulated environments, combining practical quality systems leadership with data-driven reporting and cross-functional team guidance in Spanish, English, and basic German.

Experience

Work history, roles, and key accomplishments

Sr. Quality Assurance Engineer

PerkinElmer

Oct 2021 - Jul 2026 (4 years 9 months)

Managed and defended 14+ ISO 9001:2015 certification audits across LATAM, ensuring 100% compliance. Automated document control and QMS workflows using LMS, Docebo, OCARNOS, SAP, and SharePoint, and developed Power BI dashboards for executive decision-making.

QMS ISO 9001 CAPA Power BI SAP SharePoint LMS Docebo OCARNOS Salesforce Data Analytics Compliance Document Control Root Cause Analysis Training

Analytical Control Chemist

Signa S.A. de C.V.

Feb 2018 - Apr 2021 (3 years 2 months)

Optimized procurement and inventory management, cutting material costs by 25% while maintaining 100% stock availability. Established a new development laboratory from scratch and authored comprehensive SOPs.

Procurement Inventory Management SOP Development Laboratory management Compliance Analytical Instruments Maintenance

Regulatory Affairs Associate

Signa S.A. de C.V.

Jul 2016 - Feb 2018 (1 year 7 months)

Reviewed technical documentation and validation outcomes to ensure regulatory compliance. Designed and implemented validation protocols for physical and chemical testing, and developed technical packages for clients and regulatory agencies.

Regulatory Compliance Technical Documentation Client Communication

Analytical Chemist

Abbott Laboratories

Oct 2013 - Jul 2016 (2 years 9 months)

Led analytical method transfers, feasibility testing, and stability/finished-product validation in compliance with international monographs and SOPs. Operated advanced chromatography equipment including HPLC, GC, and UV/VIS.

GCS UV Vis Method Transfer Validation Stability Testing SOPs Analytical Chemistry

QC Team Leader / Chemielaborant

Novartis

Feb 2008 - Apr 2013 (5 years 2 months)

Promoted to Team Leader to assign workflows, review documentation under strict data integrity regulations, and train analysts. Led complex OOS/OOE investigations and implemented lean laboratory projects using 5S/6S methodologies.

Team Leadership Data Integrity CAPA 5 S 6S 管理 Training Documentation Review

Analytical Development Chemist

Tecnofarma S.A. de C.V.

Sep 2006 - Feb 2008 (1 year 5 months)

Led method development, transfers, and validation initiatives for active components and materials. Designed protocols for technical and chemical testing including dissolution, assay, and impurity titration.

Method Development method validation Titrating Analytical Chemistry