Quality Expert –Risk Management, Bridgewater, NJ
Bridgewater, New Jersey
The Quality Expert in Quality Risk Management has the accountability for Quality Risk Management process, for the ITS function, in connection with the service owner and the other processes (eg .CAPA Management, Incident & problem management, Quality Intelligence, Internal Control processes, Global Quality Risk Management incl. Quality Alerts, Cyber incidents).
He/she ensures the overall performance of the Quality Risk Management process and actively contributes to ITS quality risk process improvement, training and coaching.
He acts as supervisor for assigned quality risks. He/She leads the facilitation of risk assessment and Root Cause Analysis and identification of CAPA, as SME on Risk management and in alignment with ITS Quality risk management process.
He/she contributes to the ITS risk management activities, for risk profile updates and related action plans.
He/She acts as Quality Risk management Subject Matter Expert of the ITS function during internal / external audits and inspections as required; and owns ITS Corrective Actions and Proactive Actions related to Risk Management.
He/She provides reporting on the Quality Risk areas according to the different reporting processes.
The position reports to the Head of ITS Quality Framework and Internal Control Operations.
MAJOR DUTIES & RESPONSIBILITIES:
Accountable for ITS Quality Risk Management process
- Process owner Quality Risk Management: ensures all aspects of the Quality Risk Management lifecycle are in place and in use, including: Risk Assessment, Risk Control, Risk Review, Risk Communication and escalation
- Ensures connection and integration with other processes (eg .CAPA Management, Incident & problem management, Quality Intelligence, Internal Control processes, Global Quality Risk Management including Quality Alerts, Cyber incidents).
- Ensures the overall performance of the Quality Risk Management process and actively contributes to ITS quality risk process improvement, training and coaching.
- Contributes during internal / external audits and inspections as required; and owns ITS Corrective Actions and Proactive Actions related to continuous improvement of Risk Management.
- Leads the development of Risk Management culture and principles across ITS units through awareness and trainings.
Responsible for Quality Risk Management activities
- in relation with the relevant stakeholders (eg ITS Application Owners, Businesss System Owners, Business Quality Representatives, ITS Quality representatives),
- is Quality Risk supervisor for assigned quality risks, leading the facilitation of risk assessment and Root Cause Analysis and identification of CAPA, as SME on Risk management and in alignment with ITS Quality risk management process.
- Manages communication, escalation and Quality Alerts according to the Rapid Quality Notification process as appropriate
- contributes to ITS quality risk process improvement, training and coaching.
Responsible for ITS Quality Risk Management reporting
- Defines and monitor metrics and KPIs
- provides reporting according to the different reporting processes
Contributes to ITS Risk Management activities
- in relation with the relevant stakeholders (eg ITS Risk Owners, ITS Leadership, Sanofi Risk Management…), develops, manages and monitors the ITS Risk profile in alignment with Sanofi Risk management directives.
- build the risk profile, identify risk owners, facilitate / advice for the definition of appropriate mitigation plans and monitor / report their execution.
- ensures action plans are defined and follow execution with Risk Owners
Contributes to the development and continuous improvement of the ITS Quality System, Computerized System Lifecycle methodology and ITS Processes
- In collaboration with various stakeholders manage or provide expertise for the development, harmonization, measurement and continuous improvement of the ITS quality framework and computerized system life cycle methodology, remaining focused on efficiency and consistency
FORMAL EDUCATION AND EXPERIENCE REQUIRED
- Educational degree in Health industry, Quality, computer science or related scientific or technical discipline.
- 5+ years of experience in Risk management
- 5+ years in Computerized Systems compliance in a GXP regulated environments
- Prefered : CRISC certified (ISACA)
KEY INTERNAL & EXTERNAL RELATIONSHIPS
ITS relationships :
- Quality Operations Leadership team
- All ITS Quality operations teams
- ITS Leadership Team
- Service & Product Ownership
- Service Management
- Security Expert
Stakeholders outside of ITS:
- Sanofi Risk Management
- Global Quality Risk Management
- Business Quality
- Internal Control
- Regulatory Agency inspectors
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.
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