Gonzalo San Juan Cruz
Quality Manager- Quality Assurance Head - Continuous Improvement Manager
Mexico City
Summary
Seasoned professional with extensive experience in quality assurance, supplier development, warehousing, and process improvement. Skilled in leading teams on a unionize environment, enhancing operational efficiency, and implementing quality systems across various sectors. Committed to driving customer satisfaction and operational excellence.
Collaborative leader partners with coworkers to promote engaged, empowering work culture. Documented strengths in building and maintaining relationships with diverse range of stakeholders in dynamic, fast-paced settings.
Overview
15
15
years of professional experience
1
1
Language
Work History
MANAGER, CLINICAL DATA MANAGER
Syneos Health
01.2021 - 05.2024
- Managed a team of 10 Clinical Data Associates, ensuring high-quality data cleaning/processing process while meeting key operational targets such as performance, utilization, retention, and training
- Led and coordinated the project of standardization and improvement of the resource allocation process for Clinical Data Associates (CDAs), enhancing efficiency in resource management across the LATAM region (the correct CDA in the correct project and task)
- Acted as a representative of the LATAM region in the global resource allocation initiative, improving response time, solving emergencies, and ensuring compliance with critical deliverables
- Designed and executed an improved archiving process, resulting in streamlined data management and retrieval systems
- Designed a comprehensive qualification process for Clinical Data Associates
- Participated in revising and defining the new process of the 'step rate program' for CDAs
- Acted as a point of contact for project managers of relevant Sponsors regarding resource allocation, performance issues, or upcoming deliverables for effective process management of Data Management activities
- Designed and rolled out a recognition program for the LATAM region
- Syneo´s CEO recognized this program as an example of excellent practice in recognizing the CDAs team
- Successfully developed two Clinical Data Processors for transition into Clinical Data Associate roles, strengthening the team’s capabilities
QUALITY ASSURANCE HEAD
Roche Pharmaceutical
01.2017 - 12.2020
- Identify and drive Quality Improvement in complaints related to issues with marketing, sales and supply chain
- Provide the monthly QA performance KPI reporting to Medical Director & Quality Director
- Led and coordinated the project 'New model of work at the Distribution Center, that imply changes resources, 3PL activities and new organizational chart
- Supplier development (warehousing and transportation)
- Oversaw quality assurance operations (sampling, labeling, and releasing) for commercial, psychotropic, and clinical products, including reviewing and approving batch records at the distribution center
- Oversaw recall, returns, and destruction activities of clinical commercial, psychotropic, and clinical products
- Provides Quality functional input on disposition decisions for non-conforming products
- Implement quality standards and procedures for the commercial area, ensuring product availability for existing and newly launched products
- Provide support and implement actions to correct key customer complaints
- Maintained warehouse quality systems that were compliant with GMP standards and managed third-party logistics providers and customs brokers to adhere to local and global regulations
- Led quality and regulatory audits, including those by the Ministry of Health, and coordinated internal and corporate audits
- Oversaw the implementation and sustainability of corrective action associated with all gaps identified in the internal and external audits
- Collaborated with business leaders to develop strategies and lead cross-functional teams for project completion, quality issue resolution, and quality system improvements
- Achieved up to a 50% reduction in lead times by introducing new technologies in the cold chain process for clinical and commercial products
- Developed multi-skilled personnel for increased operational flexibility
- Realized a 30% cost saving by switching to passive containers and monitoring devices for commercial & clinical product distribution
QUALITY COORDINATOR/Project Coordinator
Roche Diagnostics
01.2009 - 12.2017
- Managed the Quality System for the Diagnostics Division, including deviations, CAPAs, complaints, recalls, and KPIs, under the guidance of the Quality and Regulatory Affairs Manager
- Provided quality oversight for warehouse programs, ensuring compliance with BPAD, ISO 13485, and Cold Chain standards
- Approved area and transport qualifications at the Warehouse to assure Cold Chain integrity, including protocol and report evaluations
- Led Quality audits across ISO 9001:2008 standards, Supply Chain, Corporate, and Business sectors
- Secured three recertification cycles in the Quality Management System according to ISO 9001:2008 and achieved certification of 3PL warehouse by Global Standard
- Coordinated the project 'SIMPLEX' enhanced key processes by 30% through Lean Manufacturing – Six Sigma methodology
- Designed and implemented a due diligence process for distributors and a supplier qualification process
- Established a Business Continuity plan for Roche Diagnostic
Education
Bachelor´s Degree - Biochemical Engineering
IPN “Escuela Nacional de Ciencias Biológicas”
Transformational Leadership - undefined
ITESM
IRCA 9001:2008 Lead Auditor Certification - undefined
Bureau Veritas
Yellow Belt Certification - undefined
PEPSICO
Project Management - undefined
Skills
Quality System Management
Quality Assurance Management
Document Control Management
Operations Management
Audit and Inspection
Critical and proactive thinking
Change control management
Metrics Management
Supplier development
Continuous Improvement Process Improvement
Supply chain management
Team Leadership and team building
Lean Six Sigma
Strategic planning
Global and local relationships with partnering organizations and regulatory bodies
ISO implementation
Staff training and development Negotiation
Business planning and Budget control
Risk management
MS office
Previousjobs
- Lead auditor of quality systems, PEPSICO International
- Quality Head, PEPSICO International
Timeline
MANAGER, CLINICAL DATA MANAGER
Syneos Health
01.2021 - 05.2024
QUALITY ASSURANCE HEAD
Roche Pharmaceutical
01.2017 - 12.2020
QUALITY COORDINATOR/Project Coordinator
Roche Diagnostics
01.2009 - 12.2017
Transformational Leadership - undefined
ITESM
IRCA 9001:2008 Lead Auditor Certification - undefined
Bureau Veritas
Yellow Belt Certification - undefined
PEPSICO
Project Management - undefined
Bachelor´s Degree - Biochemical Engineering
IPN “Escuela Nacional de Ciencias Biológicas”