Senior Manager, Data Integrity

Description

ADMA Biologics is a biopharmaceutical company dedicated to developing superior products for immunodeficient patients at risk of infection. Our commitment to this underserved population drives our innovation and hands-on approach to production and development, setting us apart in the industry. If you're seeking a dynamic, innovative, and growing company in the biopharmaceutical sector that values excellence and integrity, consider joining ADMA Biologics.

We currently have an exciting opportunity for a Senior Manager, Data Integrity in Boca Raton, FL!

The Senior Manager, Data Integrity 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 will be responsible for implementing and maintaining cGMP applications throughout its SDLC. This role is critical in maintaining the accuracy, security, and quality of data within a highly regulated environment.

• Key Duties:
o 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.
o Ensure Regulatory Compliance for IT Systems: Oversee data management practices within IT to guarantee full compliance with FDA, SOX, and other relevant regulatory bodies, ensuring that all digital and automated data meets industry standards for integrity and reliability.
o 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.
o Lead GMP IT initiatives: Responsible for the entire lifecycle of cGMP applications including the implementation and maintenance of applications.
o Lead System Administrators to maintain laboratory systems including, but not limited to, LabVantage LIMS (all modules), Empower 3, and SoftMax 7
o 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.
o 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.
o 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.
o 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.
o 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.
o 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.
o 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.
• Supervisory Duties: Directs work of others within the department
• Core Competencies/Behaviors:
o Strategic Thinking: Demonstrates the ability to develop and implement long-term data governance strategies that align with organizational goals and regulatory requirements.
o Technological Acumen: Exhibits a deep understanding of IT systems and data management technologies, with the ability to effectively leverage these tools to ensure data integrity and compliance.
o Ethical Judgment: Consistently upholds the highest standards of integrity and ethics in managing data, making decisions that prioritize compliance and trustworthiness.
o Collaboration: Leads cross-functional teams with a focus on collaboration, fostering a culture of continuous improvement and shared responsibility for data integrity.
o Leadership: Motivates and guides teams to achieve excellence in data integrity practices, setting a clear vision and leading by example in driving IT initiatives forward.
• Compliance Requirements: The minimum compliance expectation for this role entails strict adherence to FDA (Food and Drug Administration) regulations and company policies governing sales and marketing activities. This includes completion of required compliance training, accurate documentation of sales interactions, and adherence to data privacy regulations. Additionally, the role requires proactive participation in compliance reviews, prompt reporting of any potential issues, and ongoing education to stay updated on relevant FDA regulations.
• Physical Requirements: Ability to sit for extended periods while working on a computer, along with occasional lifting of light objects up to 20 pounds. Clear communication skills, both verbal and written, are essential, as is manual dexterity for operating office equipment.
• Travel Requirements: Occasional travel may be required.
• Physical Location of Role: Boca Raton, FL

Qualifications

Minimum Job Requirements
• Education Requirements: Bachelor’s degree in information technology, Computer Science, Data Management, or a related technical field.
• Experience Requirements:
o 8-10 years of experience in data integrity, information management, or related IT roles within highly regulated industries such as biopharmaceuticals, biotechnology, or healthcare.
o 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 laboratory and manufacturing data integrity programs.
• Certification(s): N/A
• License(s): N/A
Preferred Job Requirements
• Preferred Education Requirements: A Master’s degree in Data Science, Information Systems, or a related discipline, particularly with a focus on data governance, cybersecurity, or regulatory compliance.
• Preferred Experience:
o Proven experience with regulatory compliance frameworks and standards (e.g., FDA, SOX, 21 CFR Part 11) as they apply to data management and IT systems.
o Proven experience supporting laboratory systems such as LabVantage LIMS, Empower 3, SoftMax 7 is strongly preferred
o Experience with MES and SAP systems is a plus