
Julien Taburel
Trainee - QA production department (Pharmaceutical Industry)

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About me
ICQA Operations Manager @ Amazon | Mastering Growth, Quality Management
Education

Training Withing Industry (Management Institute)
2016 - 2016Job Relation - Certified trainer Business Administration and Management, General Trainer at NovonordiskJob Relations training teaches supervisors how to handle problems, how to prevent them from occurring, and, most importantly, it aids in developing a logical, common sense approach to handling issues with a people-centric view. The core elements of the program are extremely conducive to teaching the basics of consensus building and individual problem solving. This program lays the groundwork upon which you can build the next step of stability into your processes. Job Relations teaches the… Show more Job Relations training teaches supervisors how to handle problems, how to prevent them from occurring, and, most importantly, it aids in developing a logical, common sense approach to handling issues with a people-centric view. The core elements of the program are extremely conducive to teaching the basics of consensus building and individual problem solving. This program lays the groundwork upon which you can build the next step of stability into your processes. Job Relations teaches the foundations of positive employee relations. Developing and maintaining these good relationships prevents problems from arising and is paramount to earn loyalty and cooperation from others. Show less

Harvard Business School
2019 -Mastering GrowthMastering Growth is a course taught by Harvard Business School (HBS) faculty in conjunction with the podcast Masters of Scale and Reid Hoffman (Co-Founder of LinkedIn).Learnings:Design with empathy to create the ultimate user experienceDetermine when and how to successfully change your company’s strategyEstablish a culture that fosters innovation and unlocks employees’ ideasAlign your company's purpose and strategic vision with stakeholder value to gain a competitive… Show more Mastering Growth is a course taught by Harvard Business School (HBS) faculty in conjunction with the podcast Masters of Scale and Reid Hoffman (Co-Founder of LinkedIn).Learnings:Design with empathy to create the ultimate user experienceDetermine when and how to successfully change your company’s strategyEstablish a culture that fosters innovation and unlocks employees’ ideasAlign your company's purpose and strategic vision with stakeholder value to gain a competitive edgeBuild the systems necessary to maintain and execute your vision at scaleEmploy different strategies at each stage of business development to achieve rapid growth Show less

Université d'Orléans
2003 - 2006Production and Quality Management
Experience

Servier
Dec 2005 - Jun 2006Trainee - QA production department (Pharmaceutical Industry)HACCP study applied on pharmaceutical packaging lines ( Hasard Analysis Critical Control Point)

CVO-EUROPE
Jun 2006 - Dec 2008IT Validation Consultant (dedicated to Pharmaceutical Industry)
PharmaSys Group
Jan 2009 - Mar 2012IT Validation Consultant (dedicated to Pharmaceutical Industry)
Genzyme Europe B.V.
Mar 2012 - May 2014IT Quality Assurance Manager & Business Quality Representative (Biotech / Pharmaceutical Industry)Assignments:• Quality Assurance responsible for both Genzyme Polyclonals sites Marcy & Gerland for all IT topics • Provide support to IT and process experts during Inspections and Corporate Audits• Business Quality Representative (BQR) of Genzyme France for other Sanofi sitesRealizations:• Definition and implementation of the full IT Quality Management System in order to obtain certifications of a brand new Biotechnology production site (Gerland).• Quality improvement of production automation systems (SCADA, RTIP, HISTORIAN, etc.) and IT systems (MES, WMS, etc.)• Strong participation as presenter during regulatory authorities inspections (ANSM, FDA, ANVISA, CFDA, etc.) Show less

Novo Nordisk
May 2014 - Jul 2017IT Quality Assurance Manager | Management Trainer (Pharmaceutical industry)Realizations:• In 6 months, Full clean-up of the 2 years old Quality backlog (more than 60 closed actions in the 6 months)• Improvement of IT Quality auditors rating from « Low level » to « Satisfactory Level »• Development of a software solution for creation of daily automatic workload planning used by 8 services into 4 Quality and Production departments Assignments:• Insure improvement of the Quality Management System according to corporate SOP and international regulatory • Define Quality KPI for IT QA department and process lead by majors stakeholders • Initiate and suggest improvements for IT Processes according to common expectations and trends based on Lean behavior• Provide support to IT experts during Inspections and Corporate Audits• As IT Quality project responsible, coordinate the whole IT Quality packages activities• Insure the level of training and estimate needs in training for the team and processes in charge Show less

LFB
Jul 2017 - Oct 2018Corporate Quality Manager & Corporate Quality Auditor (Biotechnology / Pharmaceutical Industry)Realizations• Coaching of QA Production teams: improvement of the deviation management in response to ANSM injunctions: increase from 68 to 80% in the deviation maturity level in 3 months.Assignments:• Design the Corporate's Quality Systems for pharmaceutical products and medical devices (Plasma derived products or biotechnology products) based on national and international regulations: FDA, EU GxP, and ANVISA.Ensure harmonization and compliance of affiliates by :• Creation and maintenance of the Corporate Quality Documentation• Ensuring functional partnership with affiliates to allow Corporate Documentation implementation• Reviewing / Following-up affiliates adherence to Corporate Policies and in force regulations• As qualified Auditor and expert on quality related subjects and regulations& Standards, lead Corporate Quality Audits mainly focused on quality systems approach. • Deviation management coaching and support Show less

Adents
Oct 2018 - Nov 2021Track & trace and serialization solutions dedicated to pharmaceutical industriesRealizations● Improvement of the company audit rating of the main client, member of the top 5 of the global pharmaceutical industry : from 8 major findings + 5 minor in the 2017 audit to 5 minor observations in the 2019 auditAssignments● Define the Corporate Quality policy (Europe & US)● Participate to the definition of the Business strategic orientations in regards to the EU FMD (pharmaceutical product) & EU MDR international regulations (medical device)● Implementation of the Lean Approach for Quality processes Show less
Quality Assurance & Regulatory Affairs Director (Serialization IT Software Company)
Apr 2019 - Nov 2021Regulatory Affairs Director
Oct 2018 - Apr 2019

Amazon
Jan 2022 - nowICQA Operations Manager (Directeur Assurance Qualité)
Licenses & Certifications

Job Relations - certified trainer
TWI Institute
Languages
- anAnglais
- esEspagnol
- frFrançais
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