María Guadalupe Dilsky
Frankfurt am Main
Summary
Accomplished and enthusiastic professional offering extensive 18 years' experience in managing and simplifying projects at global and local level. Willingness to take on added responsibilities to meet team goals. Hardworking with strong organizational skills eager to secure entry-level XX position.
Overview
22
22
years of professional experience
1
1
Certification
Work History
CHC Global Quality Documentation Expert
Sanofi Aventis Deutschland GmbH
06.2021 - Current
- Manage and optimize the lifecycle of the Global Quality Documents across Global Functions
- Implement simplification and optimization into the CHC Quality Documentation portfolio
- Create, implement and maintain Global Common Standard Operating Procedures
- Ensure and facilitate transversal interactions with numerous entities, including Sanofi Global Quality, CHC Global Functions, operational quality units and sites, external manufacturing hub, country affiliates, science hub, development, and distribution centers to ensure timely completion of projects
- Accomplish and lead together with the Global Business Process Owner the creation and implementation of the global common processes
- Implement, migrate, and operate the electronic Quality Management Systems (Veeva)
- Global Business Admin of the Global Content Management System (Veeva)
- Responsible for the maintenance and support to all users worldwide (106 entities, 12 000 users) of the System (Veeva-CONNECT)
- Lead translation of CHC Global Processes for manufacturing sites and relevant entities into 11 languages.
- Streamlined document control processes, resulting in increased efficiency and reduced errors.
- Developed comprehensive training materials, templates and standardized formats for consistent presentation across all company documents.
- Promoted a culture of quality within the team by emphasizing attention to detail and adherence to established standards.
- Handled multiple projects simultaneously, providing clients with prompt and high-quality service.
External Partners Coordinator
Sanofi Aventis Deutschland GmbH
12.2015 - 05.2021
- Responsible for Expense and Orders tracking, budget CAPEX, OPEX, Obligos
- Managed budgets skillfully by tracking expenses diligently and allocating resources appropriately based on priority needs.
- Coordination Training and Document Management System
- Coordination of contact of all suppliers
- Creation of Quality Agreements with Suppliers
- HSE representative, responsible for HSE audits
- Responsible for coordination of the accelerated aging studies and their document management of all devices in development
- Coordination of workbenches external laboratories
- Kanban supply inventory management system
- Responsible and process owner of the archiving process of quality relevant paper records for all devices in development.
- Increased efficiency by streamlining coordination processes and implementing new organizational systems.
- Coordinated cross-functional teams, resulting in seamless project execution and enhanced outcomes.
- Contributed to business growth by identifying opportunities for process improvement and recommending actionable solutions.
Batch Release Coordinator
Sanofi Aventis Deutschland GmbH
11.2014 - 11.2015
- Coordination of laboratory failures and data (OOS)
- Coordination the batch release testing
- Coordination of external suppliers for testing
- Creation Quality Agreements for external laboratories
- Coordination Quality Management System in GDDL.
Quality Complaint Manager
Sanofi Aventis Deutschland GmbH
02.2014 - 11.2014
- Establish an overall Complaint Management System for all devices in development
- Expert assessment of critical aspects during medical device development, technical and quality support to projects
- Ensure compliance with relevant regulations.
Quality Project Manager
Sanofi Aventis Deutschland GmbH
01.2011 - 01.2014
- Assure Quality and Compliance Standards for medical devices under development
- Expert assessment of critical Quality aspects during medical device development
- Management quality assurance program, including on-site evaluations, internal audits, and customer surveys
- Ensure regulatory standards and conduct external audits of suppliers and contractors
- Perform and report internal audits
- Improved quality processes for increased efficiency and effectiveness.
Product Technical Complaint Manager
Sanofi Aventis Deutschland GmbH
03.2007 - 12.2010
- Direction and Management of 25 employees, overseeing hiring, training, and professional growth of employees
- Overall control of the complaint management of PTCs worldwide for all manufactured products in Frankfurt site
- Creation of standard operating procedures and standard investigation methods
- Preparation for national and international audits.
Trainee/Assistant Vice President Corporate Quality
LSG Lufthansa Service Holding AG
01.2007 - 03.2007
- Translation into Spanish of the quality global quality system for implementation in Latin America
- Statistical analysis of customers' complaints and ramp safety incidents
- General support in the corporate quality daily business.
Supervisor in Pharmaceutical Manufacturing
Maver Products S.A de C.V
01.2003 - 01.2005
- Management of 50 employers, training, and professional growth of employees
- Personnel management
- Maintenance of quality control during the production
- Process optimization and achieving production targets.
Operative Consultant
Consulting Micro & Middle Businesses
09.2001 - 01.2003
- Improved client satisfaction by effectively managing multiple projects and consistently meeting deadlines.
- Developed innovative strategies for clients, resulting in increased revenue and business growth.
- Streamlined internal processes to enhance team efficiency and improve overall project outcomes.
- Collaborated with cross-functional teams to successfully deliver comprehensive solutions for clients.
Education
Master of Science - Quality, Environment, Health, and Safety
Escuela De Organización Industrial
05.2005
Bachelor of Science - Chemical Engineering major in Food Biotechnology
Colima University
01.2003
Diploma, Consulting Program -
Consulten
12.2002
Skills
- Quality Document Management
- Digitalization of GMP Documentation
- PTC Management
- Quality processes
- Quality Standards
- Change control Process
- Compliance Data Integrity
- Business partnership development
- Internal / External Liaison
- Cross-functional teams
- Intercultural mindset
- External Party Relationship Management
- Internal / External Communications
- Strategic Partnership Management
- Internal / External Audits
- Internal /External Liason
- Problem-solving abilities
- Budget Preparation
- Project planning and development
- Project Management
- Contract Management
- Transversal Interaction at local and global level
Certification
Scrum Master
Accomplishments
- Lead and creation of the Global Process for implementation of Common Process at local level for CHC
- Coordination of the translation in different languages of the electronic Quality Management System - Veeva
- Creation and establishment of an overall complaint management system for devices in development
- Creation and implementation of the process for digitalization and archiving quality GxP documents for medical devices in development
- Creation of the coordination plan for the accelerating clinical studies for devices in development
Languages
Spanish
English
German
Birth
06/07/79
Personal Information
Nationality: Mexican and German
Publications
Diversity as a success factor, https://www.sanofi.de/de/sanofi-in-deutschland/news-storys/adventskalender-2020/10-guadalupe-dilsky
Timeline
CHC Global Quality Documentation Expert
Sanofi Aventis Deutschland GmbH
06.2021 - Current
External Partners Coordinator
Sanofi Aventis Deutschland GmbH
12.2015 - 05.2021
Batch Release Coordinator
Sanofi Aventis Deutschland GmbH
11.2014 - 11.2015
Quality Complaint Manager
Sanofi Aventis Deutschland GmbH
02.2014 - 11.2014
Quality Project Manager
Sanofi Aventis Deutschland GmbH
01.2011 - 01.2014
Product Technical Complaint Manager
Sanofi Aventis Deutschland GmbH
03.2007 - 12.2010
Trainee/Assistant Vice President Corporate Quality
LSG Lufthansa Service Holding AG
01.2007 - 03.2007
Supervisor in Pharmaceutical Manufacturing
Maver Products S.A de C.V
01.2003 - 01.2005
Operative Consultant
Consulting Micro & Middle Businesses
09.2001 - 01.2003
Master of Science - Quality, Environment, Health, and Safety
Escuela De Organización Industrial
Bachelor of Science - Chemical Engineering major in Food Biotechnology
Colima University
Diploma, Consulting Program -
Consulten
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