Associate Director, Data Integrity & IT Operations

Adma Biomanufacturing - Boca Raton, FL

Full-time - Senior

Boca Raton, FL

About the position

The Associate Director, Data Integrity and IT Operations at ADMA Biologics is responsible for leading the development and implementation of IT-driven data governance strategies. This role ensures the integrity and regulatory compliance of all digital data across the organization's systems, which is critical in maintaining the accuracy, security, and quality of data within a highly regulated environment.

Responsibilities

• Lead the creation and execution of data governance policies focusing on IT systems to ensure data integrity, accuracy, and security.
• Oversee data management practices within IT to guarantee compliance with FDA, EMA, and other regulatory bodies.
• Conduct comprehensive audits of IT systems to identify and address data integrity risks or discrepancies.
• Develop and deliver specialized training programs for IT and cross-functional teams on data integrity best practices.
• Collaborate with IT, Quality Assurance, Manufacturing, Regulatory Affairs, and other departments to maintain data integrity across all stages of the product lifecycle.
• Lead continuous improvement initiatives within IT to enhance data quality and integrity through new technologies and best practices.
• Identify, assess, and mitigate risks to data integrity within IT systems, developing proactive strategies for compliance and product quality.
• Guide the selection, validation, and deployment of IT systems to meet data integrity standards and regulatory requirements.
• Maintain and oversee the accuracy and compliance of all IT-related data documentation.
• Regularly update senior management on the status of data integrity initiatives and provide insights to enhance IT governance.

Requirements

• 8-10 years of experience in data integrity, information management, or related IT roles within highly regulated industries.
• 3-5 years of leadership experience in IT management, with a demonstrated ability to lead cross-functional teams.
• Proven experience with regulatory compliance frameworks and standards (e.g., FDA, EMA, 21 CFR Part 11).
• Extensive experience with IT systems and data management technologies, including validation, security, and governance.
• Strong understanding of industry best practices for data integrity and information security, particularly within GxP environments.
• Familiarity with cloud-based solutions and the challenges of maintaining data integrity in cloud environments.

Benefits

• Paid holidays
• Disability insurance
• Health insurance
• Dental insurance
• Tuition reimbursement
• Paid time off
• Vision insurance
• 401(k) matching
• Pet insurance