JOB SUMMARY
We are looking for a Digital quality Lead to drive the Quality and compliance partnership and support for the Digital Commerce scope, one of the Key domains under the Digital products unit.
The Digital Quality Lead – Digital Commerce is a key member of the Digital Quality Operations team, providing mission-critical Quality and Compliance expertise to the Digital Commerce Unit. The incumbent is the point of contact and Quality Partner for the domains under Digital Commerce, covering areas such as Omnichannel Marketing, Omnichannel Sales and Direct sales, providing end-to-end Quality & Compliance oversight for this scope by ensuring the Quality and compliance of Projects & Applications/ Products.
This position covers an exciting and innovative business scope with a variety of critical Digital/IT solutions built on both established and emerging technologies, such as CRM (notably the 1CRM program ) , eCommerce and Web technologies , providing 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.
The position will potentially partner with stakeholders in other Digital Units, since Digital commerce products and applications are deployed across different Global Business Units ( e.g. Digital SPC, Gen Med, Vaccines, CHC …)
The position reports to the Head of Digital Quality Operations for GBUS, Commerce and Innovation.
PRINCIPAL DUTIES AND RESPONSIBILITIES
Major duties and responsibilities
Partner with Digital Product, Program, Development and Technology teams in Digital Commerce (and other business areas as required)
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.
Review the Project and Product/application portfolio, identifying the Digital QO resource and support needs.
Computerized System (CS) Assurance/Validation and Application Lifecycle Management:
Advise and guide project and product teams on and oversee validation activities, in line with Agile principles.
Advise on and support the effective quality management and auditing of third parties, notably 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.
KEY INTERNAL & EXTERNAL RELATIONSHIPS
Digital Stakeholders:
Digital 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
Internal Control
Internal Audit
Corporate Risk Management
Data Privacy Office
External Stakeholders:
Regulatory Agency inspectors
External auditors
Suppliers / Service Providers
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, industry standards, regulations (GxP, SOX, Data Privacy, etc.), and trends
Experience with Commercial / Sales and marketing products and technologies is a key differentiator, (e.g. CRM, eCommerce and website campaign management technologies)
Very good understanding of Digital life-cycle processes and required controls to ensure reliability and compliance of Computerized Systems and services (Agile methodology, application support and maintenance, ITIL processes, COBIT ...)
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 Digital areas contributing to regulated projects or system lifecycle activities ( *candidates with experience in Sales and Marketing digital projects are welcome in the process, even without technical background on Quality management and operations )
As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. All US based roles require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities.
Fully vaccinated, according to the CDC, an individual is considered to be “fully vaccinated” fourteen (14) days after receiving (a) the second dose of the Moderna or Pfizer vaccine, or (b) the single dose of the J&J vaccine. Fully vaccinated, for new Sanofi employees, is to be fully vaccinated 14 DAYS PRIOR TO START DATE.
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
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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.
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