Dessire Vargas
Toronto,,ON
Summary
I have contributed to maintain high-quality standards and ensure regulatory compliance of pharmaceutical operations for 12 years. I create value by managing quality systems, projects, and implementing continuous improvement initiatives to ensure compliance and costs reduction. At the same time, I imprint passion in each task thus stimulating an environment of collaboration, trust, positivity, and growth.
Overview
15
15
years of professional experience
Work History
Compliance Manager
Sanofi
Toronto, ON
01.2023 - Current
- Identify gaps and develop improvement initiatives with area management and other stakeholders to reduce the number of compliance issues in our department, achieving GMP and KPI compliance.
- Develop and lead investigation strategies to define the scope, root cause, and impact of deviations based on risk management.
- Support implementation leaders to initiate Corrective and Preventive Actions (CAPAs), monitor effectiveness review (ER), Change Control Request (CCR) in the Quality System as required with a clearly defined scope and timeline.
- Lead continuous improvement initiatives as outputs of investigations and provide compliance direction. Escalate any issues to ETS Platform Leaders via Deviation/CAPA review board.
Technical Services Compliance Specialist
Sanofi through UQSI
Toronto, ON
07.2021 - 12.2022
- Identified and remediated more than 500 non-conformances to ensure that commissioning and validation processes met project timelines and complied with Canadian regulations.
- Managed the updating of electronic management systems to grow the project deliverables to 400% compared to the previous year.
- Coordinated multiple tasks with system owners, maintenance personnel, trades, and others to manage investigations, change controls, and implement corrective and preventive actions.
Quality Assurance Specialist
Sanofi
, Mexico
03.2019 - 09.2019
- Designed and implemented part of the quality management system of the organization to comply with COFEPRIS regulations and corporate standards (included SOP writing among others).
- Identified 20 improvement opportunities through multiple gap analyses of the site practices and implemented action plans along with the stakeholders.
- Created and executed dynamic training programs to engage around 100 employees toward a Quality culture.
Quality Systems Specialist
Roche
, Mexico
01.2017 - 03.2018
- Coordinated and prepared reports of the Annual Product Quality Review (APQR) for 60 products delivered before the expected date by implementing new work schemes.
- Identified improvement opportunities in the site operations and collaborated with diverse stakeholders in designing adequate remediation plans.
- Facilitated biweekly meetings of the Site Quality Committee to monitor compliance metrics of the Quality Management System.
Regulatory Compliance Coordinator
Roche
, Mexico
09.2014 - 12.2016
- Participated as a leader of a multinational and cross-functional project to transfer the manufacture of 12 products to different plants worldwide in compliance with international health regulations.
- Developed and coordinated remediation plans to mitigate compliance findings derived from changes in the regulatory environment, investigations, or audits.
- Led meetings, presentations, and worked hand-to-hand with global partners to define the regulatory and submission strategy of the new manufacturing sites.
- Acted as a regulatory advisor and technical expert to assess deviations, change controls, investigations, risks assessments, and compliance of site operations to ensure product quality and safety.
Senior Quality Control Analyst
Roche
, Mexico
11.2008 - 08.2014
- Managed the stability program in compliance with international health regulations (ICH, FDA, Health Canada, EMEA, COFEPRIS, etc.).
- Completed training in Genentech Inc. (USA) and Roche (Switzerland) to implement analytical testing of biological products on site.
- Trained, coached, and coordinated a team of 10 QC analysts.
Education
Postgraduate Certificate - Global Business Management (2 years)
Centennial College
Toronto, ON2021
Master of Science - Molecular Biology (2.5 years)
University of Guanajuato
Mexico2008
Bachelor of Science - Chemistry (5 years)
University of Guanajuato
Mexico2005
Skills
- Advanced skills with Microsoft Office and Quality Management System softwares (LIMS, Empower, SAP, Phenix, Qualipso)
- Expertise in analytical and biological testing
- Extensive practical knowledge in GMPs
- Outstanding analytical, research, and critical thinking abilities
- Effective negotiation and problem-solving skills
- Highly organized and detail-oriented
- Excellent communication skills (including technical writing)
- Experience and proven success working with global and cross-functional teams
Languages
English
Spanish
Timeline
Compliance Manager
Sanofi
01.2023 - Current
Technical Services Compliance Specialist
Sanofi through UQSI
07.2021 - 12.2022
Quality Assurance Specialist
Sanofi
03.2019 - 09.2019
Quality Systems Specialist
Roche
01.2017 - 03.2018
Regulatory Compliance Coordinator
Roche
09.2014 - 12.2016
Senior Quality Control Analyst
Roche
11.2008 - 08.2014
Postgraduate Certificate - Global Business Management (2 years)
Centennial College
Master of Science - Molecular Biology (2.5 years)
University of Guanajuato
Bachelor of Science - Chemistry (5 years)
University of Guanajuato
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