Data Integrity Specialist

Job description

Job Description

The Novartis Cell & Gene Technical Development and Manufacturing team is seeking a Data Integrity Specialist in Morris Plains, NJ.

Novartis provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, cost-saving generic and biosimilar pharmaceuticals and eye care. Novartis has leading positions globally in each of these areas. In 2017, the Group achieved net sales of USD 49.1 billion, while R&D throughout the Group amounted to approximately USD 9.0 billion. Novartis Group companies employ approximately 122,000 full-time-equivalent associates. Novartis products are sold in approximately 155 countries around the world. For more information, please visit http://www.novartis.com.

The purpose of this position is to increase awareness and understanding of data integrity and to drive and monitor change management activities necessary for an environment and culture of Data Integrity Excellence in Morris Plains.

• Serve as an SME for DI-related inquiries / trainings.
• Serve as deputy for DI CGT Lead
• Drive, monitor and assure delivery of the CGT DI Plan, including the DI communication and engagement plan
• Track and communicate DI-related AQWA records as needed to ensure timely completion
• Perform and facilitate Data Lifecycle Process Maps (DLPMs) to identify DI risks and de-fine mitigation strategies
• Perform, facilitate and support DI improvements to documents, systems and processes
• Create DI-related AQWA actions from walkthroughs, DLPMs, etc.
• Create, track and communicate DI-related KPIs and metrics
• Manage the update of required DI metrics and information (e.g., NTO, SQC, QRB)
• Work with investigators and deviations personnel to ensure DI-related deviations are properly initiated, flagged, communicated and escalated
• Track and trend DI-related deviations to identify areas of concern and opportunity
• Schedule and facilitate DI Learning map sessions and other trainings
• Schedule and help in facilitation of DI team meetings
• Continuously improve data integrity knowledge base and understanding: Identify training needs, and ensure availability of appropriate and functionally relevant training materials; where training does not exist, facilitate creation of material and delivery of training.
• Participate in design and delivery of activities to engage shop floor associates in strengthening quality culture, leveraging the network of functional DI SMEs/DI Champions
• Drive sustainable improvement in detecting and mitigating DI risk by working with SMEs to embed DI elements into site processes and programs
• Support preparation for regulatory / health authority inspections and/or response development for DI related topics
• Assess Change Controls for Data Integrity impact
• Facilitate / support the rollout of DI-related guidance, directives, GOPs, etc. from NTO, GQA, etc.
• Delivering CGT DI Plan actions
• Reducing DI related reoccurring deviations
• Ensuring readiness for health authority inspections for DI topics
• Evolving and institutionalizing the overall DI program and its elements

Posting Title

Data Integrity Specialist

Desired profile

Minimum requirements

Bachelors or higher in life sciences, Engineering, Chemistry, Pharmaceutical
Bachelors with 5 years of experience, or Masters with 3 years of experience, in Pharmaceutical Industry.
Specific experience in GDocP and Data Integrity, and familiarity with AQWA/Trackwise
Job Type

Full Time
Country

USA
Work Location

Morris Plains
Functional Area

Quality
Division

Novartis Technical Operations
Business Unit

NTO BTDM
Employment Type

Regular
Company/Legal Entity

Novartis Pharmaceuticals
EEO Statement

The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.