Digital Risk and Compliance Lead

Cambridge, MA, United States

Sanofi Group Digital Risk and Compliance Lead Cambridge , Massachusetts Apply Now As a Digital Quality Lead, you will proactively engage with product teams to provide guidance and consultation on Digital solution lifecycle risks and controls.

The Digital Quality Lead is accountable for anticipating and resourcing the quality and compliance needs of the Digital Data teams. The Digital Quality Lead will provide key quality expertise to establish pragmatic compliance controls supporting selection of data platforms, establishment of global data architecture, implementation of data governance tools at scale, enabling data science capabilities, and responsible design/development/deployment and use of AI enabled solutions.

Critical aspect of the role includes defining an agile quality and compliance strategy that supports Digital Data unit in their effort to establish a standardized, resilient, and sustainable data pipeline - including data sources, data quality, data governance, data management and master data management.

If you are passionate about Digital/IT and Quality, if you want to make a difference in how we work, you should come and join a dynamic team with great values!

The position is based in Bridgewater or Cambridge (US) or Budapest (Hungary) with opportunity to collaborate with internal and external stakeholders located all around the globe. Based on prior experience of the selected applicant, upskilling opportunities will be provided.

MAIN RESPONSIBILITIES

Serve as the primary digital risk & compliance point of contact forDigital / Business solution owners and teams.

Provide cross-domain guidance on topics including risk profileexecution, control implementation, and risk management/actionplanning.

Manage extended team interactions, engaging subject matterresources where needed.

Provide support and guidance during audit, inspection, andassurance activities.

Identify opportunities to further enable Digital / Business self-serviceand scale & optimize controls implementation, work with Digital Quality leadsto drive change.

Deliver training / awareness sessions (e.g., lunch & learns) on digital risk &compliance topics to upskill stakeholders.

Demand/Delivery Mgmt. / Stakeholder Mgmt.

Work closely with the Digital Data teams to review the project and application portfolio to mobilize quality support to meet stakeholder needs.

Accountable for the appropriate quality staffing of PODs, Programs & Services

Oversee, monitor, and report on all Digital Quality Operations activities within domain of responsibility.

Plan the workload for domain of responsibility.

Advise, educate, 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 Mgmt. System

Define Quality and Compliance Standards for emerging regulatory concerns relating to data science, artificial intelligence, machine learning, etc.

Contribute to the development and continuous improvement of the Digital Quality System, Computerized System Lifecycle methodology and Digital Processes

Audits & Inspections / Controls Assurance

Collaborate with Business System owners, Business Quality and Solution Center 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

Support internal quality assessments and reviews for assigned projects and applications to ensure compliance and / or application of best practices.

Support the execution of the ICM and SOX Campaigns, including the support, monitoring, and implementation of corrective and preventive actions.

Support IT Risk Management through identification, characterization, and development of mitigation plans, in collaboration with Digital Units and other stakeholders.

REQUIREMENTS

Demonstrated experience with quality support in data governance and management setting. Experience with data science / analytics in a regulated context and in an agile environment is a key differentiator.

Ability to identify and act on next wave of regulatory compliance risks relating to data science, AI, ML, …

Adaptability to a changing and highly dynamic work environment.

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 training and learning management topics.

Strong interpersonal skills to build effective relationships with a variety of stakeholders.

QUALIFICATIONS:

Bachelor’s Degree or equivalent in Computer Science, Engineering, or relevant field

8+ years of experience Quality Management, Computerized Systems compliance (GxP, SOX, Data Privacy) or Information Technology contributing to regulated projects or system lifecycle activities.

Experience with management of data integrity, data governance, and data management 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.

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