Aryaz Zomorodi
Laguna Niguel
Summary
Highly experienced and self-aware Quality Assurance professional with over 15 years of leadership experience in the Life Sciences industry. Adept in Computerized System Validation/Software Validation/Computer Software Assurance, Artificial Intelligence, Quality Management Systems, Data Integrity, Lean and Six Sigma methodologies. Proven track record in successfully navigating regulatory inspections and consistently delivering results that drive organizational efficiency and compliance. Seeking new challenges and opportunities to bring my expertise to the forefront and drive continuous improvement utilizing my technical skills and soft skills.
Overview
15
15
years of professional experience
1
1
Certification
Work History
Associate Director Systems Quality
SpringWorks Therapeutics
09.2023 - Current
- Supported transition from CSV to CSA, eliminating waste and driving efficiency through a risk-based approach.
- Spearheaded a cross-functional Kaizen Event to tackle regulatory gaps and opportunities.
- Managed audit program related to GxP technology platforms and service providers
- Assisted senior leadership in identifying and remediating compliance gaps.
- Provided technology expertise to enable compliance with global health authorities expectations, and requirements related to electronic records, electronic signatures, and data integrity.
- Provided QA oversight for all IT GxP Validation projects inclusive of all aspects of the SDLC, including Change Controls/Deviations/CAPAs related to GxP systems/services.
- Developed strategies for the technology inspection readiness, including preparation, direct interaction, and responses to global health authority inspections
Senior Manager, CSV
Pfizer Inc
08.2022 - 04.2023
- Managed CSV team for all GxP business system projects.
- Provided audit support and served as key member of inspection readiness team.
Senior Manager, CSV
Arena Pharmaceuticals, Inc.
11.2020 - 08.2022
- Company Overview: (acq. by Pfizer Inc)
- Served as the QA lead on all GxP business system projects, including implementation of eQMS, enhancements to EDMS (Veeva), and retirement of legacy systems.
- Managed CSV (Computer Systems Validation) process for multiple projects/products, ensuring compliance with FDA regulations and industry standards.
- Developed and oversaw CSV activities for validation of computer systems and software, including creating validation plans, protocols, and reports.
- Evaluated risk associated with validation activities and implemented mitigation solutions.
- Managed change control process for all computer systems and software.
- Served as a primary point of contact for FDA and other regulatory agencies.
- Ensured compliance with data integrity and security standards.
Senior Quality Manager
Avanos Medical
07.2019 - 11.2020
- Managed team (5 employees) in quality system development, continuous improvement programs, and/or projects involving department, crossfunctional, and cross business unit teams.
- Served as Validation (including Process, Test Method and CSV) program process owner, responsible for authoring / revising program SOPs to streamline and align with current business model and implementing on-going process improvements where identified.
- Served as Quality Assurance lead and successfully implemented SAP S/4 HANA.
- Provided Validation metrics and KPIs for Blue Ribbon Team that was viewed weekly by senior and executive management.
- Successfully implemented multiple enhancements to Validation processes, including moving Validation Deviations, Quality Review Board (field actions) to paperless processes within the Quality Systems Management software (EtQ Reliance).
Quality Capabilities Program Leader - I
Halyard Health
09.2014 - 07.2019
- Provided project leadership, expertise and counsel that resulted in the development and implementation of CAPA, Deviations, Design History File & Validation, Change Control, and other quality processes, capabilities, and tools for the Enterprise.
- Interpreted requirements for specific businesses and support the implementation of strategies and systems to meet business objectives and requirements.
- Provided technical leadership and expertise to support large complex facilities, facilities producing highly regulated products and/or corporate staff teams.
Software Quality Engineer
I-Flow, LLC/Kimberly-Clark
08.2010 - 09.2014
- Project leader for pre and post implementation of new Quality System automation software overseeing 5 consultants.
- Identified systems requiring CSV (Computerized System Validation) and assessed risk based on CFR 21 Part 11 and Part 820 and lead software remediation activities.
- Wrote QA procedures, advised senior management on CSV quality practices.
- Coordinated validation activities related to Quality Systems including but not limited to: planning, integration, training, problem resolution, communication with Corporate Quality IT, etc.
Education
Master of Science - Applied Artificial Intelligence
University of San Diego
San Diego05-2025
Bachelor of Arts - Information Systems and Decision Sciences
Cal State Fullerton, College of Business and Economics
Fullerton, CA01.2010
Skills
- Quality Management Systems
- 21 CFR Part 11
- 21 CFR Part 820
- 21 CFR Part 210
- 21 CFR Part 211
- ISO 13485
- ISO 9001
- ICH Q9
- ICH Q10
- Lean
- Auditing
- Data Integrity
- Root Cause Analysis
- Key relationship management
- Fiscal oversight
- Strategic leadership
Certification
- Certified Quality Auditor (ASQ), 05/18
- Certified Lean Six Sigma Black Belt (The Council for Six Sigma Certification), 07/19
Timeline
Associate Director Systems Quality
SpringWorks Therapeutics
09.2023 - Current
Senior Manager, CSV
Pfizer Inc
08.2022 - 04.2023
Senior Manager, CSV
Arena Pharmaceuticals, Inc.
11.2020 - 08.2022
Senior Quality Manager
Avanos Medical
07.2019 - 11.2020
Quality Capabilities Program Leader - I
Halyard Health
09.2014 - 07.2019
Software Quality Engineer
I-Flow, LLC/Kimberly-Clark
08.2010 - 09.2014
Master of Science - Applied Artificial Intelligence
University of San Diego
Bachelor of Arts - Information Systems and Decision Sciences
Cal State Fullerton, College of Business and Economics
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