Data Integrity Specialist
Newark Metro Area, NJ
REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:
Must have expert GMP, Quality, and Data Integrity knowledge.
Must be able to effectively identify Data Integrity compliance gaps and communicate in an impactful manner to management and the group with clarity and a high level of accuracy.
Must have the ability to provide guidance related to the interpretation of data integrity requirements; across the Summit and Warren, NJ sites.
Must be able to critically review reports while effectively inputting and expressing Data Integrity principles.
Must have experience with Computer System Validation and expertise with 21 part 11 requirements.
Completes routine tasks with no supervision; Confident in making decisions in their subject matter area; Able to work proactively. Drives continuous improvement and improves efficiency and productivity within the group or project.
Leads cross functional project teams driving performance and results. Skilled at getting resources and information from internal and external contacts;
Strong project management skills with the ability to effectively communicate
Builds and leverages relationships and provides advice internally within function.
Recognizes data integrity risks, develops contingency plans, ensures remediation efforts are driven to completion.
Able to fully interpret complex data Integrity results and situations independently and articulate recommendations for resolution.
DUTIES AND RESPONSIBILITIES:
Support the Data Integrity Gap Assessment of GMP areas in scope of the program and ensure compliance with Global DG/DI policies and standards
Responsible for ensuring systems at 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 leading, reviewing and approving data integrity assessments across facilities of new and existing systems and processes to ensure compliance with regulatory requirements and company established requirements for data integrity.
Responsible for leading, reviewing and approving data integrity periodic reviews and performing risk monitoring of implemented systems across all sites to ensure continued compliance.
Where necessary, drive mitigation and remediation when data integrity gaps are identified.
Identify and work with functions at Summit and Warren CAR T to ensure data risk is 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
Prepare and deliver communications to GMP functions leadership regarding identified risks, mitigations, and overall project status updates.
EDUCATION AND EXPERIENCE:
Relevant college or university degree preferred. Equivalent combination of education and experience acceptable; Bachelor of Science or equivalent
Minimum 8 years relevant work experience and minimum 4 years of leadership experience;