Description Overview

The Data Integrity Professional is responsible for ensuring the accuracy, consistency, and reliability of data across systems and processes. This role plays a critical part in maintaining compliance with FDA regulatory standards, supporting quality assurance, quality control and continuous improvement in data governance practices.

Please note, this is a first shift opening.

Scope of the Role

As a strategic partner in quality and compliance, the Data Integrity Professional ensures that data across systems is accurate, secure, and aligned with regulatory expectations. This role drives site-wide initiatives to assess risk, implement corrective actions, and uphold the highest standards of data governance.

• Leading and facilitating data integrity risk assessments across Operational QA/QC systems and processes.
• Conducting internal audits focused on data integrity compliance and identifying areas for improvement.
• Collaborating cross-functionally to investigate data discrepancies and implement effective corrective and preventive actions (CAPAs).
• Providing strategic direction and oversight for site-wide data integrity initiatives, including risk mitigation planning and execution.
• Supporting continuous improvement efforts by promoting best practices in data governance and regulatory compliance.
• Communicating findings and recommendations clearly to stakeholders at all levels, ensuring alignment and accountability.

Experience Required

This position will require excellent communication skills and unquestioned integrity. Familiarity with systems such as SAP, LIMS, TrackWise and Empower is required. In addition, the ability to influence results without authority is of great importance.

• The incumbent must possess basic knowledge of manufacturing, packaging and quality testing systems in a pharmaceutical environment.
• Relevant analytical skills and a working knowledge of FDA regulatory standards.
• Excellent communication skills are essential, including well-developed people skills, the ability to collaborate effectively with staff members at all levels, and strong technical writing skills.
• Computer literacy is required.
• This position requires a four-year degree in a scientific or closely aligned field.
• A minimum of five years’ experience working in an FDA regulated industry is required.
• Experience in the interpretation and application of FDA requirements and cGMP is preferred.