Senior Manager, Data Integrity
ADMA Biologics, Inc.
Full-time
Remote friendly (Boca Raton, FL)
United States
IT
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Role Summary
Senior Manager, Data Integrity responsible for leading IT-driven data governance strategies, ensuring the integrity and regulatory compliance of all digital data across the organization’s systems, and maintaining cGMP applications throughout their SDLC in a highly regulated environment.
Responsibilities
- Lead the creation and execution of data governance policies for IT systems to ensure data integrity, accuracy, and security across manufacturing, laboratory, and quality systems.
- Oversee IT data management practices to ensure compliance with FDA, SOX, and other regulatory bodies; ensure digital and automated data meet industry standards for integrity and reliability.
- Regularly perform audits of IT systems to identify and mitigate data integrity risks or discrepancies.
- Manage the entire lifecycle of cGMP applications including implementation and maintenance.
- Lead System Administrators to maintain laboratory systems (e.g., LabVantage LIMS, Empower 3, SoftMax 7).
- Develop and deliver training programs for IT and cross-functional teams on data integrity best practices and regulatory compliance.
- Collaborate with IT, QA, Manufacturing, Regulatory Affairs, and other departments to maintain data integrity across product lifecycle.
- Drive continuous IT improvement to enhance data quality and integrity through new technologies and best practices.
- Identify, assess, and mitigate data integrity risks within IT systems and develop proactive strategies to safeguard compliance.
- Guide selection, validation, and deployment of IT systems meeting data integrity standards and regulatory requirements.
- Maintain accuracy and regulatory compliance of IT data documentation, including validation records, archiving, and retrieval processes.
- Provide updates to senior management on data integrity initiatives and IT governance to reduce compliance risks.
Qualifications
- Experience Requirements:
- 8-10 years in data integrity, information management, or related IT roles in highly regulated industries (biopharma, biotech, healthcare).
- At least 3-5 years of leadership experience in IT management with ability to lead cross-functional teams in data integrity programs for laboratory and manufacturing data.
Education
- Bachelor’s degree in information technology, Computer Science, Data Management, or related technical field.
Preferred Experience
- Experience with regulatory frameworks (FDA, SOX, 21 CFR Part 11) as they apply to data management and IT systems.
- Experience supporting LabVantage LIMS, Empower 3, SoftMax 7; MES and SAP systems a plus.
- Extensive experience with IT systems and data management technologies, including validation, security, and governance of enterprise data systems.
- Strong understanding of data integrity and information security in GxP environments; familiarity with cloud-based solutions and security regulations.
- Project management skills with experience in Agile or Six Sigma; ability to lead large IT projects.
- Advanced certifications in data governance, information security, or regulatory compliance (e.g., CISSP, CISA, CDMP).
- Preferred Education: Master’s degree in Data Science, Information Systems, or related field with focus on data governance, cybersecurity, or regulatory compliance.
Skills
- Data governance and data integrity
- Regulatory compliance (FDA, SOX, 21 CFR Part 11)
- IT systems lifecycle management and validation
- Laboratory IT systems (LabVantage LIMS, Empower 3, SoftMax 7)
- Risk assessment and mitigation
- Cross-functional collaboration
- Training and development
- Cloud security and governance
- Project management (Agile/Six Sigma)
Additional Requirements
- None specified beyond listed qualifications