Azmi Simms

Data Integrity, Computer System Validation (CSV), and Digital Quality professional with 10+ years of experience supporting regulated life sciences environments across Manufacturing, Quality, Validation, Engineering, Automation, and Operations. Proven track record leading validation lifecycle activities, governance-aligned change control processes, audit readiness initiatives, computerized system compliance efforts, and cross-functional digital transformation programs supporting GxP environments. Experienced supporting enterprise platforms including KNEAT, ServiceNow, SAP ERP, Databricks, Aspen IP.21, Veeva-enabled workflows, LIMS, MES, SQL databases, and cloud-based reporting environments.

Recognized for strengthening data integrity, improving compliance maturity, reducing operational risk, and enabling inspection-ready digital systems aligned with FDA, EMA, ICH, GAMP 5, 21 CFR Part 11, and Annex 11 expectations.

Senior Data & Automation Specialist — Data Governance, Validation & Compliance - GlaxoSmithKline (GSK)

(2020-01 - 2025-01)

Provided enterprise-level leadership supporting validation governance, data integrity, audit readiness, reporting controls, and digital quality initiatives across GMP-regulated manufacturing and quality environments. Partnered with Manufacturing, Quality Assurance, Quality Control, Validation, Engineering, Automation, MSAT, Materials Management, and Operations stakeholders to strengthen compliance, improve digital process maturity, and support risk-based decision making.

• Executed, reviewed, and approved 50+ KNEAT validation workflows supporting Aspen IP.21, Statistica, Continued Process Verification (CPV) applications, reporting systems, and operational technology platforms.
• Led validation lifecycle activities including protocol execution, validation testing, User Acceptance Testing (UAT), workflow approvals, change controls, documentation review, and implementation readiness.
• Applied risk-based Computer Software Assurance (CSA) principles to validation activities, focusing testing and documentation effort on critical system functionality, compliance risk, and data integrity controls.
• Supported validation alignment across GxP computerized systems, reporting environments, and process validation initiatives.
• Assessed reporting workflows, data pipelines, and computerized systems to identify control gaps, traceability weaknesses, manual reconciliation risks, and data integrity concerns.
• Implemented governance-aligned validation checkpoints, documentation standards, and evidence requirements that improved audit traceability and inspection readiness.
• Strengthened reporting reliability by reducing manual reconciliation, improving source consistency, standardizing intake processes, and enabling repeatable monitoring of quality metrics.
• Supported enterprise data integrity initiatives across Manufacturing, Validation, and Quality organizations.
• Initiated and managed ServiceNow change controls, including impact assessments, testing support, approval routing, remediation follow-up, documentation updates, and implementation activities.
• Authored, revised, and maintained validation documentation, governance frameworks, compliance procedures, and lifecycle records supporting GxP computerized systems.
• Developed audit-readiness materials supporting validation evidence, documentation consistency, inspection preparedness, and remediation activities.
• Supported regulatory audit preparation and remediation initiatives within highly regulated GMP environments.
• Integrated and aligned data sources across SAP ERP, Databricks, LIMS, MES (Syncade), SQL databases, Python automation, and operational technology systems.
• Supported Continued Process Verification (CPV) reporting, workflow governance, and validation-aligned process improvements.
• Reduced batch-release decision latency by approximately 30–40% through workflow optimization, reporting standardization, automation, and stronger governance controls.
• Supported Veeva-enabled change management training, stakeholder adoption activities, and compliance-aligned implementation of regulated digital workflows.
• Delivered executive reporting, risk insights, compliance updates, and governance recommendations to Manufacturing, Quality, Validation, Engineering, Automation, and Operations leadership.
• Led workshops and adoption activities supporting reporting, automation, and digital visibility tools.
• Delivered approximately 30–40 training sessions and mentored 10–15 associates on digital systems, reporting processes, compliance requirements, and operational best practices.

Biopharmaceutical Manufacturing Associate II / Lead - GlaxoSmithKline (GSK)

Supported upstream and downstream biologics manufacturing operations within GMP-regulated environments.

• Participated in deviation investigations, CAPA activities, remediation support, effectiveness checks, process walkthroughs, and audit readiness initiatives.
• Supported batch documentation, production monitoring, quality records, and validation-aligned manufacturing processes.
• Served as a qualified trainer supporting onboarding, equipment qualification, process discipline, and GMP compliance expectations.

Chief Creative Officer and Systems Strategist - YAZMI USA LLC

(2014-01)

• Designed governance, reporting, and operating structures supporting multi-stakeholder initiatives, process clarity, decision rights, accountability, and structured decision-making.
• Developed stakeholder-facing narratives, operating models, and reporting concepts that improved coordination, execution visibility, communications, and leadership alignment.

Master of Science - Applied Information Technology - Cybersecurity - George Mason University

Bachelor of Science - Information Technology - Cybersecurity - Strayer University

Bachelor of Science - Biochemistry Technology - Concordia University