Sanofi Group Digital Quality Expert – R&D in Bridgewater, New Jersey
Digital Quality Expert – R&D
The Digital Quality Expert – R&D 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, Digital Quality Operations for R&D.
The incumbent will cover a diverse R&D business scope, ranging from Research through Pharmacovigilance, with a variety of critical Digital/IT solutions built on both established and emerging technologies. She/he provides Quality & Compliance expertise and advice on Quality Services related to Project & Application Support, Audit & Inspection Support, Risk Management and Education & Compliance Readiness.
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 strategic projects and system lifecycle activities with global scope.
Based on prior experience of the selected applicant, upskilling opportunities will be provided.
Computerized System (CS) Assurance/Validation and Application Lifecycle Management:
Advise and guide Digital project and product teams on and oversee compliance and validation activities in collaboration with Business Quality in a rapidly evolving technology environment
Advise on and support the effective quality management of third parties, including SaaS / cloud suppliers
Lead risk assessment, quality assurance, quality/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 throughout the scope of activity and ensure that Quality & Compliance risks are proactively detected, assessed and mitigated.
Promote quality education and compliance readiness practices to develop quality and compliance awareness and expertise in Digital R&D 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
Digital Quality Framework and System Lifecycle Methodology:
Contribute to the continuous improvement of the 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.
FORMAL EDUCATION, EXPERIENCE AND SKILLS 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
Strong critical thinking and problem-solving skills
Demonstrated leadership and ability to effectively influence teams 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 internal and external stakeholders, such as Digital teams, Business Quality, internal and external auditors/inspectors, suppliers and service providers
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 QUALIFICATIONS: Digital QO will provides 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
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.