About the Job

The LEDP Release quality coordinator ensures adherence to Sanofi quality standards for each new release of the LEDP platform, including:

• Proper classification of new release (e.g. minor /major version) and adherence to related release process based on content.

• Right quality of documentation at each step of the development, testing and release process, as well as application support post release.

LEDP is Sanofi’s backbone to new product development and industrialization. It establishes a data continuity between the CMC and Launch units. It enables paperless tech transfers and serves as a foundation for other digital tools such as Launch Readiness Control tower, One click TT, One click Dossier, Integrated Collaborative Scheduling and others.

LEDP is based on Dassault Systemes 3DExperience platform. It involves both Saas and on premise environments (GxP and not GxP), which are configured and customized to meet Sanofi requirements. An integrated development and continuous integration process involving the different platform environments is defined. The Saas and on premise Sanofi platforms have different lifecycles, driven by business requests and Out of the Box software evolution.

Currently, there is a new release every 6 months for the on premise and every 10 weeks for the Saas platforms, but we are planning to increase the frequency of updates to every 3 weeks for both.

The LEDP Release quality coordinator also provides guidance to the team in the application of Sanofi standards, ensures proper application of the thoughtful-risk-taking approach, is a key contributor in audit & inspections, and ensures Risk Management and Education & Compliance Readiness of the LEDP Digital Team.

The position provides an opportunity to work in a dynamic, international context in relationship with :

Digital stakeholders:

· Digital quality and risk advisory teams.

· LEDP Product owners, functional, development, digital tech, testing, devops and support teams

Stakeholders outside of Digital Organization:

· Global Quality/Business Quality

· Internal Control

· Internal Audit

· Corporate Risk Management

· Data Privacy Office

External Stakeholders:

· Suppliers / Service Providers

Duties:

Computerized System (CS) Assurance/Validation and Application Lifecycle Management:

• Manage end to end platform documentation

• Advise and guide platform and product teams and oversee validation activities in collaboration with Digital and Business Quality

• Advise on and support the effective quality management of third parties, including service providers (e.g. integrator, SW editor design authority) and SaaS / cloud suppliers

• Lead risk assessment, quality assurance and validation strategy definition and oversee their execution in collaboration with external service providers

Quality Risk Management:

• Lead risk assessment, quality assurance and validation strategy definition and oversee their execution in collaboration with external service providers

Compliance Readiness:

• Promote quality education and compliance readiness practices to develop quality and compliance awareness and expertise to minimize exposure during health authority inspections and internal/external audits.

• Collaborate with Business System Owners, Business Quality, Digital Quality to prepare for regulatory inspections and internal audits, respond to questions and address findings through corrective/preventive action plans to improve compliance and effectiveness of the LEDP platform in regard to Quality Management system

Integrated Quality Framework and System Lifecycle Methodology:

• Collaborate with Business System Owners, Business Quality, Digital Quality to prepare for regulatory inspections and internal audits, respond to questions and address findings through corrective/preventive action plans to improve compliance and effectiveness of the LEDP platform in regard to Quality Management system

Education:

• Bachelor’s degree in a scientific, engineering or IT discipline

• 5+ years of experience in Quality Management, compliance (GxP, SOX, Data Privacy) or Information Technology contributing to regulated projects or system lifecycle activities

Required Skills:

Hard skills and knowledge:

· Broad understanding of information technology solutions, theory and principles and their application to multiple areas of specialty.

· Broad, in-depth knowledge of Quality Management, industry standards, regulations (GxP, SOX, Data Privacy, etc.), and trends

· Very good understanding of IT life-cycle processes and required controls to ensure reliability and compliance of Computerized Systems and services (project methodology, application support and maintenance, ITIL processes, operational activities...)

· Validation of Computerized Systems in a GxP environment

· Application of Agile and Lean practices to System Lifecycle activities in a regulated environment

· Use of Life Cycle management tools, esp. Jira/Confluence

· Implementation of new technologies such as PLM, SaaS systems, RPA and Machine Learning in a regulated context

Soft skills:

• Strong critical thinking and problem-solving skills

• Demonstrated leadership and ability to effectively influence and make decisions

• Excellent written and oral communication in English, including ability to effectively educate various audiences on quality and compliance topics

• Strong interpersonal skills to build effective relationships with a variety of stakeholders

• Ability to work effectively and collaboratively in an international, multi-cultural and multidisciplinary environment

• Ability to adapt to a changing and highly dynamic work environment

• Curiosity with respect to new technology and its application in pharmaceutical R&D

Pursue progress, discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!