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An established industry player is seeking a Data Integrity Compliance Lead to oversee compliance with data integrity standards in research and development. This pivotal role involves ensuring adherence to regulations like Good Laboratory Practice (GLP) and Good Clinical Practice (GCP) throughout the data lifecycle. The ideal candidate will bring extensive experience in quality compliance within the life sciences or pharmaceuticals, guiding teams in maintaining high standards of data integrity. Join a forward-thinking organization where your expertise will drive strategic improvements and enhance compliance efforts, making a significant impact on research initiatives.
States considered: Preferred Kalamazoo, MI/US Eastern Time Zone, Remote will be considered
Role Description
Position Overview
The Veterinary Medicine Research and Development (VMRD) Data Integrity Compliance Lead will serve as the organizational expert in ensuring compliance with data integrity standards and regulations (e.g., Good Laboratory Practice (GLP), Good Clinical Practice (GCP)) throughout the data lifecycle, from collection to archival, particularly for electronic systems used to support regulated research studies. This role serves as the subject matter expert on data integrity and system validation, providing guidance, training, and oversight to maintain compliance. The Lead will collaborate with cross-functional teams to review existing practices, address gaps, support audits, and drive strategic improvements as well as set the vision for the future. Responsibilities include monitoring regulatory updates, developing training programs, reviewing and supporting documentation practices, and implementing risk-based controls to enhance compliance and audit readiness, and remediation. The role requires close coordination with internal stakeholders (e.g., VMRD Quality Assurance, Zoetis Tech and Digital (ZTD) Risk and Compliance, ZTD Business Partners, System Owners, Business Process Owners, Test Facility Management, Study Directors, Principal Investigators, Laboratory and Clinical Data Management) to support system validation, regulatory alignment, documentation, and continuous improvement initiatives.
Qualifications
Competencies