Associate Director, Data Integrity & IT Operations

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 organization’s systems. This role is critical in maintaining the accuracy, security, and quality of data within a highly regulated environment.

RESPONSIBILITIES:

• 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 Leadership

  Regularly update senior management on the status of data integrity initiatives, providing insights and recommendations to enhance IT governance and reduce compliance risks.

  
  

QUALIFICATIONS:

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

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

• 401K plan with employer match and immediate vesting
• Medical, Vision, Life and Dental Insurance
• Pet Insurance
• Company paid STD and LTD
• Company Paid Holidays
• 3 Weeks’ Paid Time Off (within the first year)
• Tuition Assistance (after the first year)
• Easily accessible to Tri-Rail
• Company paid shuttle to the Boca Tri-Rail station