II - JOB SUMMARY
The Digital Quality Lead Factory 4.0 is a key member of the Digital Quality Operations team providing mission-critical Quality and Compliance expertise to the Digital Industrial Unit.
The incumbent is the point of contact and Quality Partner for the Industrial development & assets business area / Service Lines in Digital IA & FO;
she / he provides end-to-end Quality & Compliance oversight for this Digital business area by 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 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 through contribution to a variety of projects and system lifecycle activities.
III KEY INTERNAL & EXTERNAL RELATIONSHIPS
Digital stakeholders :
Quality Operations Leadership team
Digital Units Leadership team members
Digital Units Service / Domain managers and Application teams
Stakeholders outside of Digital Organization :
Global Quality / Business Quality
Corporate Risk Management
Data Privacy Office
External Stakeholders :
Regulatory Agency inspectors
Suppliers / Service Providers
IV KNOWLEDGE, SKILL, FORMAL EDUCATION & EXPERIENCE REQUIREMENTS
Minimum requirements for assignment to this job)
Knowledge and Skills Required :
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, lndustry 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 and HP ALM
Implementation of new technologies such as 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 the covered perimeter
Formal Education and Experience Required :
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
PRINCIPAL DUTIES AND RESPONSIBILITIES
Major duties and responsibilities
Partner with Digital Product, Program, Development and Technology teams
in Digital Industrial Factory 4.0 and Quality (and other 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 and validation 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 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.
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.