Associate Director, Data Integrity

ADMA Biologics is a biopharmaceutical company relentlessly committed to creating superior products for immunodeficient patients at risk for infection. It is our devotion to this underserved population that fuels us and our hands-on approach to production and development that sets us apart. If you are looking for a dynamic, innovative, growing company in the biopharmaceutical industry that is committed to excellence and integrity, then consider ADMA Biologics. We currently have an exciting opportunity available for an Associate Director, Data Integrity and IT Operations in Boca Raton, FL.

The Associate Director, Data Integrity and IT Operations will lead the development and implementation of IT-driven data governance strategies, ensuring the integrity and regulatory compliance of all digital data across the organizations systems. This role is critical in maintaining the accuracy, security, and quality of data within a highly regulated environment.

• Develop and Implement IT-Driven Data Governance Strategies : Lead the creation and execution of data governance policies, focusing on IT systems to ensure the integrity, accuracy, and security of data across manufacturing, laboratory, and quality systems.
• Ensure Regulatory Compliance for IT Systems : Oversee data management practices within IT to guarantee full compliance with FDA, EMA, and other relevant regulatory bodies, ensuring that all digital and automated data meets industry standards for integrity and reliability.
• Conduct IT-Focused Data Integrity Audits : Regularly perform comprehensive audits of IT systems, including databases, software applications, and digital workflows, to identify and address any data integrity risks or discrepancies.
• Lead IT Training and Education Initiatives : Develop and deliver specialized training programs for IT and cross-functional teams, ensuring they understand and adhere to data integrity best practices within the context of IT systems and regulatory compliance.
• Collaborate with Cross-Functional IT and Business Teams : Partner with IT, Quality Assurance, Manufacturing, Regulatory Affairs, and other departments to ensure data integrity is maintained across all stages of the product lifecycle, leveraging IT systems and technology.
• Drive Data Quality Improvement through IT Innovations : Lead continuous improvement initiatives within IT, focusing on enhancing data quality and integrity through the adoption of new technologies, tools, and best practices.
• Manage Data Integrity Risks in IT Systems : Identify, assess, and mitigate risks to data integrity within IT systems, developing proactive strategies to safeguard compliance and product quality across digital platforms.
• Oversee IT System Validation and Implementation : Guide the selection, validation, and deployment of IT systems, ensuring they meet stringent data integrity standards and align with the organization's operational goals and regulatory requirements.
• Ensure Robust IT Documentation Management : Maintain and oversee the accuracy, accessibility, and regulatory compliance of all IT-related data documentation, including system validation records, data archiving, and retrieval processes.
• Report on Data Integrity Status to IT Le adership : Regularly update senior management on the status of data integrity initiatives, providing insights and recommendations to enhance IT governance and reduce compliance risks.

Experience Requirements :

In addition to competitive compensation, we offer a comprehensive benefits package including :

ADMA Biologics, Inc. uses E-Verify to confirm the employment eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please visit www.dhs.gov / E-Verify.

ADMA Biologics, Inc. is an Equal Opportunity Employer.

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