Position Summary

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.

Essential Functions (ES) and Responsibilities

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.

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.

Regularly perform comprehensive audits of IT systems, including databases, software applications, and digital workflows, to identify and address any data integrity risks or discrepancies.

Responsible for the entire lifecycle of cGMP applications including the implementation and maintenance of applications.

Lead System Administrators to maintain laboratory systems including, but not limited to, LabVantage LIMS (all modules), Empower 3, and SoftMax 7

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.

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.

Lead continuous improvement initiatives within IT, focusing on enhancing data quality and integrity through the adoption of new technologies, tools, and best practices.

Identify, assess, and mitigate risks to data integrity within IT systems, developing proactive strategies to safeguard compliance and product quality across digital platforms.

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.

Maintain and oversee the accuracy, accessibility, and regulatory compliance of all IT-related data documentation, including system validation records, data archiving, and retrieval processes.

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

Job Responsibilities or Job Requirements

Competencies

Experience Requirements

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 laboratory and manufacturing data integrity programs.

Education Requirements: Bachelor’s degree in information technology, Computer Science, Data Management, or a related technical field.

Preferred Experience

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.

Proven experience supporting laboratory systems such as LabVantage LIMS, Empower 3, SoftMax 7 is strongly preferred

Experience with MES and SAP systems is a plus

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.

Strong project management skills with a track record of successfully leading large-scale IT projects related to data governance and system validation, including experience with methodologies like Agile or Six Sigma.

Advanced certifications in data governance, information security, or regulatory compliance, such as Certified Information Systems Security Professional (CISSP), Certified Information Systems Auditor (CISA), or Certified Data Management Professional (CDMP).

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.

Compliance Requirements (ES)

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.