The ITS Expert Quality – R&D and Medical is a key member of the ITS Quality Operations team providing mission-critical Quality and Compliance expertise to the ITS R&D and Medical Units and will be reporting to the Head, ITS Quality Operations for R&D and CMO.
The incumbent will provide Quality & Compliance expertise and services to different business areas and Service Lines across ITS R&D and Medical, including Project & Application Quality Support, Audit & Inspection Support, Risk Management and Education & Compliance Readiness.
This position covers a diverse R&D and Medical business scope with a variety of critical ITS solutions built on both established and emerging technologies.
Additionally, it provides an opportunity to work in a dynamic, international Quality Operations team, while at the same time gaining experience with and contributing to a variety of projects and system lifecycle activities in support of the discovery and development of life-saving new medicines.
Based on prior experience of the selected applicant, upskilling opportunities will be provided.
· Computerized System (CS) Validation and Application Lifecycle Management:
· Advise and guide project and application 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
· Ensure compliance of projects and applications with applicable regulatory and internal requirements by leading risk assessment, validation and testing strategy definition and overseeing their execution in collaboration with external service providers
· Quality Risk Management :
· Work with ITS Risk Managers and Service Lines to proactively address and mitigate Quality and Compliance risks
· Contribute to operational excellence in application management and support through management of Corrective and Preventive Actions
· Audit and Inspection Readiness and Support:
· Collaborate with Business System Owners, Business Quality and ITS Service Line representatives 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
· Quality Management System and System Lifecycle Methodology :
· Contribute to the continuous improvement of the ITS Quality Management System and System Lifecycle methodology and its continuous evolution to adapt to new technologies and ways of working
· Contribute to the education and upskilling of the ITS community on Quality and Compliance topics
Formal Education, Experience and Skills Required:
· Bachelor’s degree in a scientific, engineering or IT discipline
· 3+ years of experience in Quality Management and compliance (GxP, SOX, Data Privacy) or Information Technology contributing to regulated projects or system lifecycle activities
· Strong problem-solving skills
· Excellent written and oral communication in English
· 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 a regulated pharmaceutical R&D environment
Preferred Qualifications: ITS will provide necessary upskilling for final candidate
· Experience in the validation of Computerized Systems in a GxP environment
· Experience in the application of Agile System Lifecycle methodologies
· Experience implementing new technologies such as SaaS systems, RPA and Machine Learning in a regulated context
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.
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.