Le contenu du poste est libellé en anglais car il nécessite de nombreuses interactions avec nos filiales à l’international, l'anglais étant la langue de travail.  

JOB MISSION

The Digital Quality Lead – Research & Early Development is a key member of the Digital Quality Operations team providing mission-critical Quality and Compliance expertise to the Digital R&D Unit and will be reporting to the Head of Digital Quality Operations for R&D.

The incumbent will partner with and ensure end-to-end Quality & Compliance oversight primarily for the Research & early Development business area / Service Lines in Digital R&D; this includes ensuring the delivery of Quality Services related to Project & Application Support, Audit & Inspection Support, Risk Management and Education & Compliance Readiness.

This position covers an exciting and innovative R&D business scope with a variety of critical Digital/IT solutions built on both established and emerging technologies.

The position provides an opportunity to work in a dynamic, international Quality Operations team, while at the same time gaining experience across different business areas in R&D through contribution to a variety of projects and system lifecycle activities.

Based on prior experience of the selected applicant, upskilling opportunities will be provided.

RESPONSIBILITIES

Partner with Digital Product, Program, Development and Technology teams

• In Digital Research, early Development and CMC (and other R&D business areas as required) to ensure Quality by Design in every project and throughout the system and technology life cycle to ensure Digital/IT products and technologies are fit for their intended use and meet – where applicable – regulatory requirements

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

• Advise and guide project and product teams on and oversee validation activities in collaboration with Business Quality
• Advise on and support the effective quality management of third parties, including SaaS / cloud suppliers
• Lead risk assessment, quality assurance, validation and testing strategy definition and oversee their execution in collaboration with external service providers

Quality Risk Management

• Foster a Quality Risk Management and Internal Control Culture and ensure that Quality & Compliance risks are proactively detected, assessed, and mitigated

Compliance Readiness

• Promote quality education and compliance readiness practices to develop quality and compliance awareness and expertise in the Digital Research & early Development function and beyond to minimize exposure during health authority inspections and internal/external audits
• Collaborate with Business System Owners, Business Quality and Digital Product owners 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 Quality Management system

Integrated Quality Framework and System Lifecycle Methodology

• Contribute to the continuous improvement of the integrated Digital Quality framework to enable agile ways of working and the implementation of new technologies while ensuring compliance with all applicable regulations (GxP, Sarbanes-Oxley, etc.) and standards

PROFILE

• 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
• 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

PREFERRED QUALIFICATION

Digital QO will provide necessary upskilling for final candidate

• Experience in the validation of Computerized Systems in a GxP environment
• Experience in the application of Agile and Lean practices to System Lifecycle activities in a regulated environment
• Experience in the use of Life Cycle management tools, esp. Jira/Confluence and HP ALM
• Experience implementing new technologies such as SaaS systems, RPA and Machine Learning in a regulated context

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.