The Sr. Manager of Data Integrity will oversee the development and execution of IT-driven data governance strategies to ensure the integrity and regulatory compliance of digital data across the organization’s systems.

Key Responsibilities:

• Lead the design and execution of data governance policies focused on IT systems to maintain the integrity, accuracy, and security of data across manufacturing, laboratory, and quality systems.
• Supervise data management practices within IT to ensure full compliance with regulatory standards such as FDA, EMA, and other relevant authorities, ensuring digital and automated data aligns with industry requirements for integrity and reliability.
• Perform regular audits of IT systems, including databases, software applications, and digital workflows, to identify and resolve potential data integrity risks or inconsistencies.
• Design and deliver specialized training for IT and cross-functional teams to ensure adherence to data integrity best practices within IT systems, emphasizing regulatory compliance.
• Partner with IT, Quality Assurance, Manufacturing, Regulatory Affairs, and other departments to ensure data integrity is maintained throughout the product lifecycle, leveraging IT systems and technologies.
• Lead initiatives to continuously improve data quality and integrity through the adoption of new technologies, tools, and best practices within IT systems.

Qualifications:

• In-depth knowledge of regulatory compliance frameworks and standards (FDA, EMA, 21 CFR Part 11) in relation to data management and IT systems.
• Strong understanding of industry best practices for data integrity and information security, particularly within GxP environments.
• 8+ years of experience in data integrity, information management, or related IT roles within highly regulated industries such as biopharmaceuticals, biotechnology, or healthcare.
• 3+ years of leadership experience in IT management, with proven ability to lead cross-functional teams in implementing and overseeing data integrity programs.