Job Description

Responsibilities

• Responsible for executing data integrity documentation periodic reviews and performing risk monitoring of implemented systems across all sites to ensure continued compliance.
• Responsible for assisting with the implementation of Global Data Integrity Processes at the site and ensuring that Global programs are implemented on-time.
• Assist in ensuring local site activities are harmonized with Global DG/DI standards.
• Provide feedback and support to GMP areas in scope during process improvement, while ensuring compliance with Global DG/DI policies and standards.
• Responsible for ensuring systems at Summit West, NJ CAR T facilities comply with data life cycle requirements from initial data creation/recording to archival and decommissioning. This includes, but is not limited to, data management (e.g., data creation, data processing, review, reporting), data security, data traceability, process mapping, data backup/restore, electronic signature/electronic record linking and data audit trails.
• Responsible for creating and executing data integrity assessments of new and existing systems including, but not limited to, manufacturing and laboratory systems to ensure compliance with regulatory requirements and company established requirements for data integrity.
• Drive mitigation and remediation when data integrity gaps are identified.
• Work with functional area SMEs at Summit West CAR T facility to ensure data risks are identified, remediated and prevented.
• Seek out and recommend to management opportunities for increased data integrity program efficiencies and operational improvement through modifications to current systems, implementation of new systems and more efficient use of established systems.
• Provide the GMP functions any updates regarding data integrity regulations that they may be impacted by.

Knowledge & Skills

• Must have familiarity with GMPs, Quality, and Data Integrity principles.
• Must be familiar with system validation principles.
• Must be familiar with the ALCOA+ principles and their application to both electronic and paper data.
• Must be able to effectively interpret problems and communicate in an impactful manner to management and the group with clarity and a high level of accuracy.
• Must be able to note data integrity impact in potential situations or issues and process science-based solutions across a majority of the job function.
• Must provide guidance to other employees in the interpretation and correction of data integrity issues; across the Summit West, NJ Site's CAR T Facility.
• Must be able to critically review and author technical reports while effectively inputting and expressing Data Integrity principles.
• Completes routine tasks with little to no supervision; Confident in making decisions in their subject matter area; Able to work proactively and identify opportunities for improvement.
• Drives continuous improvement projects and improve efficiency and productivity within the group or project.
• Support and lead cross functional project teams driving performance and results.
• Coordinate projects with multiple functional areas. Able to recognize potential delays and notify management with proposed recommendations for resolution.
• Strong project management skills with the ability to effectively communicate.
• Builds and leverages relationships and provides advice internally within function and with global cross-functional teams.
• Recognizes data integrity risks, develops contingency plans, ensures remediation efforts are driven to completion.
• Able to fully interpret complex data Integrity results and situations within the data integrity team and articulate recommendations for resolution.
• Must have familiarity with Computer System Validation and expertise with 21 part 11 requirements.

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