Sanofi Group Lead, GRA Data Quality Control and Continuous Improvement (DQC&CI) in Cambridge, Massachusetts
GRA Data QC & CI's mission is to:
Be the primary group responsible for data quality check processes and activities for Global Regulatory Affairs (GRA). .
Works to ensure that GRA data has been checked for completeness, consistency, timeliness, and compliance with established data standards.
Checks for compliance with Key Performance Indicators (KPIs) that have been established related to GRA data.
Provide oversight for the GRA data QC activities. Data quality analysts examine complex data and turn it into information and insight to inform business decisions and to ensure quality of data and information. .
Monitor performance and quality control plans to identify any issues or ways to improve systems and database design.
GRA provides services globally to all R&D units and to all Sanofi affiliates (fully connected sites plus all countries with industrial and/or commercial operations).The GRA DQC & CI team primarily supports GRA but also supports Pharmacovigliance (PV) reporting by checking the quality of data used for Health Authority Reports, Inspections, and Audits.
Special Note about Scope of this position: Accountability for DATA Quality remains in the Business unit and is not part of this role.
Primary areas of responsibility include:
Provides vision and strategy for the GRA Data Quality Control (QC) and Continuous Improvement (CI) framework.
Be the primary owner of the GRA Data QC and CI Framework including QC processes, and tracking and maintaining requirements and business rules for quality checks. Provides oversight for operation of QC processes to ensure followed and to monitor for issues, efficiencies
Ensures that the formal data QC process and methodology is defined, documented, implemented and followed to ensure quality oversight of GRA data and to meet the needs of the user community.
Supports GRA projects as needed to plan for data QC needs after implementation. Leads the development of GRA business requirements and business rules for GRA data.
Ensures highest quality information implementing, driving and overseeing Data QC processes, Coordinating with data owners on resolving identified data issues, Tracking business rules and mapping to data for quality checks, and by analyzing issues and fixes on a regular basis to identify improvements to prevent issues from occurring in the first place
This role and function is responsible for the GRA data quality checks but is not responsible for the data that is being checked. Business Units are responsible for entering the data and for the quality of the data that they enter. .
Duties and Responsibilities::
The GRA QC &CI function is an integral member of GRA and the DQC&CI team responsibilities include:
Develops vision and strategy for the GRA Data Quality Control (QC) and Continuous Improvement (CI) function.
Drives the collection, documentation, tracking and maintenance of business rules for quality checks of GRA data. This involves collaborating with representatives across GRA functions to capture (collect and document) business rules needed to ensure quality of GRA data.
Develops, implements, maintains and owns the Data QC Framework, including the business processes for quality checks of data, and technical requirements for reports needed to support these quality checks. Framework tracks the Subject Matter Experts and “Quality Check Business Owners” who can authorize changes to quality checks when needed.
Owns Framework that also provides ability for any user to submit data quality issues. These should be tracked and communication provided when issue resolved. Defines and documents tools, processes, roles and responsibilities to support the QC framework.
Thoroughly understands business context to to determine business impact of quality issues.
Analyzes and determines root cause for data quality errors and make recommendations for long term solutions. Research and determine scope and complexity of issue so as to identify steps to fix issue
Is the business owner for QC Process and QC Edit Checks.
Develop strategy for conduct of quality checks to ensure adherence to data quality standards
Identify areas of improvement to improve data quality and develops strategy to address them
Analyze, query and manipulate data according to defined business rules and procedures
Partners with business to ensure that identified quality issues get resolved.
Partners with business to establish quality standards and business rules for quality measures. Provide recommendations for quality improvements
Assures and delivers a high level of data quality awareness across GRA
Maintains a thorough understanding of Regulatory business data, its use and system data models.
Using thorough knowledge (of Regulatory data, data models) and collected business rules, translates these to requirements for reports and/or process steps for checking the data. Assures reports meet the business needs.
Collaborates with the GRA Reporting & Analytics function for requirements related to reports and analytics used by the Data QC group.
Designs and implements QC process steps and leverages QC reports to analyze against system data configuration and models, data definitions, and business rules for the data objects and fields to confirm data quality. Reviews data to identify data quality issues and directs data owners to request data fixes.
Evaluate large data-sets for quality including data completeness, consistency, accuracy, timeliness. Identify, compare and resolve data quality problems
Collaborates with GRA Data Governance as needed to identify, define and implement business rules, update hover(help) text for data fields, and /or request changes to dictionary terms with the goal of improving data quality and eliminating data issues.
Collaborates with the GRO Business Process Excellence function to develop strategy for needed data QC checks and process steps during conduct of projects. Collaborates to develop and implement process improvements to enhance overall data quality
Manages and provides oversight of offshore contractors supporting the QC process. Understand work responsibilities for contractors, and expected deliverables, and process to be followed. Using this knowledge, meets with contractors regularly to review their work, progress, status and quality of deliverables. When process issues are identified, directs contractors to conduct root cause analysis of issues, and works to resolve issues.
Analyse QC issues to identify and interpret trends or patterns in complex data sets
Knowledge, Skills and Competencies :
Thorough knowledge of Regulatory Affairs/Operations domain and regulatory requirements. understands Regulatory business data, Regulatory Information Management (RIM) and other GRA system data models, data definitions, and business rules for data.
Strong understanding of PV function and data
Strong understanding of audit/inspection processes, company approach and need for accurate responses to queries
Solid understanding of the different domains within GRA including Labeling, Affiliates (regions and countries), Global Business Units (GBUs), Document Authoring and Management. Submissions Publishing, Data Governance, Data Management, and Reporting and Analytics needs.
Lead multi-disciplinary teams and interface with upper level management of support and client organizations. Strong interpersonal skills to be effective in global teams
Solid knowledge of of data relationships and impact of data fields upon each other.
Expert analytic skills and experience in problem-solving techniques.
Experience in clearly documenting QC specifications.
Demonstrated ability to multi-task and to work in a global team environment, customer focused and action oriented.
Demonstrated ability to work with shifting priorities to meet project requirements; self-motivated
Excellent attention to detail. Strong organizational, and communication skills, both written and verbal
Focus on high quality deliverables.
Ability to work under pressure to meet short deadlines
Knows when sufficient data has been collected to solve a problem and demonstrates the ability to understand the great importance of database accuracy.
Experience with customer service with multiple interfaces with partners and customers within and outside of Sanofi (this includes all R&D, Affiliates, Industrial Affairs and commercial.
Aptitude for computer systems and software, and have strong analytical abilities.
Minimum of a BS degree in mathematics, computer science or engineering, or scientific area.
10 to 15 years of industry experience.
Thorough knowledge of Regulatory Affairs/Operations domain and regulatory requirements including PV
Strong Veeva VAULT RIM knowledge Working knowledge of regulatory requirements in multiple jurisdictions, specifically as they pertain to Registration Tracking.
Experience with working across boundaries and interact with varying levels of leadership
Strong interpersonal skills to be effective in the leadership of global teams.
Language: Sufficient English to work in an international context.
Strong analytical abilities, be able to condense complex data into digestible information for use in other parts of the business, and have an aptitude for numbers.
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.