Gabriel Torres Zamora
IT Quality Manager
Zapopan, Jalisco
Summary
Dynamic and results-driven professional with over eight years of progressive experience in IT Quality Management within the pharmaceutical industry, with a strong focus on Computerized Systems Validation (CSV) and Medical Device Software Lifecycle. Proven track record of providing IT quality support and expertise to project and BAU teams, ensuring compliant delivery of IT GxP applications, as well as providing expert guidance on Medical Device Software regulatory requirements to ensure delivery of safe and effective SaMD applications. Adept at leading teams, driving strategic programs, and fostering a culture of quality excellence.
Overview
6
6
years of professional experience
5
5
years of post-secondary education
Work History
IT Quality Manager–R&D/Commercial/IGNITE GDL Lead
AstraZeneca
Zapopan, Jalisco
09.2022 - Current
- Lead a team responsible for providing IT quality expertise to support the E2E lifecycle of IT systems, ensuring compliant delivery and maintenance of the R&D/Commercial/IGNITE IT project portfolio, with a specific focus on a risk based approach to validation and ensuring the validated state of GxP applications through it’s lifecycle.
- IT Quality SME for providing Medical Device software guidance and expertise to internal and external stakeholders, aligning with industry trends and regulatory requirements.
- Implemented a monitoring system to ensure Change Control Records are closed on time, eliminating overdue records, and maintaining no escalations up to date, thus ensuring data integrity and compliance with regulatory requirements.
- Ensure the ITQM team received training, processes, and exposure to upskill their capabilities to meet future IT needs, including providing support to innovative technologies like AI, SaMD, or GxP applications supporting Cell therapy products.
- Provide IT Quality Support for delivery of IT systems to digitize the management of Chain of Identity/Chain of Custody of Cell Therapy products (TrakCel)
- Lead auditor for several SaMD and IVD software suppliers, ensuring software suppliers used for development of Medical Device software during clinical and commercial phases provide services compliant with medical device regulations and/or safe and effective products.
IT Quality Manager
AstraZeneca
Zapopan, Jalisco
06.2020 - 09.2022
- Provided ITQM support to a wide variety of projects in different SET areas, including Operations, Commercial, R&D, as well as projects with a wide variety of regulatory complexities (GxP, SOx, SaMD, Connected medical devices, Data privacy) and technology complexity including cloud platforms, SaaS, Machine Learning, ensuring adherence to Computerized Systems Validation (CSV) , data integrity standards and applicable regulations and industry best practice (i.e. 21 CFR part 11, 21 CFR 820, ISO 13485, GAMP 5, etc.).
- Led as ITQM Programme lead for the Enterprise Quality Vault (EQV) platform, that included the Enterprise Content Management System (ECMS), Global Pharmaceutical Quality System (GPQS) and Global Validation Lifecycle Management System (GVLMS), developing a master validation strategy that ensured compliance with applicable GxP requirements at the platform and application level.
- Lead as ITQM for all the data migration from the current Enterprise Document Management System (AZ-Doc) to the new Enterprise Content Management System (ECMS)
- Stepped in as CSV SME for the EQV program inspections
- Supported the development of the AZ Medical Device Firmware SOP, to support software development activities for medical devices with firmware, where AZ acts as the legal manufacturer.
- Delivered in the ADF portal a page that provides interactive supporting content about the AZ SaMD Quality Management System, for increasing adoption and awareness of this new processes.
Sr. IT Quality Analyst
AstraZeneca
Zapopan, Jalisco
09.2018 - 06.2020
- Provided ITQM support to innovation projects, including one of the first Medical Mobile application of AZ, the iFeNO+ study app, collaborating closely with Medical Devices Quality and Regulatory Affairs representatives.
- Collaborated as the main IT Quality SME in the development of the AstraZeneca Software as a Medical Device (SaMD) Quality Management processes.
Education
Bachelor of Science - Chemistry And Pharmaceutical Technologies
Universidad Nacional Autónoma De México
Mexico, Mexico 07.2007 - 12.2012
Skills
- Track record managing IT Quality and compliance activities, including supporting root cause analysis, follow up of Periodic Review CAPAs and IT Quality support during inspections and internal audits
- In-depth knowledge of current GxP and Medical Device software guidelines and regulations
- Solid foundational knowledge of GCP regulations, able to understand and explain to IT teams how they apply to software
- Highly developed problem-solving and conflict resolution skills
- Strong interpersonal and communication abilities, with a focus on influencing and leading teams
- Project management skills with a focus on quality, compliance and lean thinking
- Strategic thinking, coaching, and mentoring capabilities
- Focus on doing the right thing and adhering to high ethical standards, with a proven record of professional credibility and trust
Accomplishments
Won the AstraZeneca Guadalajara GTC Director Awards 2019 for the development of the SaMD QMS.
Affiliations
Member of the Combination Products and Medical devices coalition
Timeline
IT Quality Manager–R&D/Commercial/IGNITE GDL Lead
AstraZeneca
09.2022 - Current
IT Quality Manager
AstraZeneca
06.2020 - 09.2022
Sr. IT Quality Analyst
AstraZeneca
09.2018 - 06.2020
Bachelor of Science - Chemistry And Pharmaceutical Technologies
Universidad Nacional Autónoma De México
07.2007 - 12.2012
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