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Data Integrity Compliance Lead

Zoetis

Kalamazoo (MI)

Remote

USD 60,000 - 80,000

Full time

30+ days ago

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Job summary

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.

Qualifications

  • 5-10 years experience in life sciences or pharmaceuticals focusing on compliance.
  • Knowledge of global data integrity standards and system validation.

Responsibilities

  • Ensure compliance with data integrity standards throughout the data lifecycle.
  • Collaborate with teams to review practices and support audits.

Skills

Detail-oriented
Strong communication skills
Analytical skills
Leadership skills
Interpersonal skills
Self-driven
Initiative

Education

Bachelor’s degree in quality compliance, regulatory affairs, or IT

Tools

Data integrity standards
System validation
Electronic applications and data systems

Job description

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

  • Bachelor’s degree or equivalent experience in quality compliance, regulatory affairs, or IT, preferably with 5-10 years contextual experience in the life sciences or pharmaceuticals.
  • Knowledge of global data integrity standards and system validation.
  • Experience supporting compliance projects, audits, and training programs as applied to data integrity associated with electronic applications and data systems.
  • Familiarity with application life cycle processes and documentation approaches and templates.

Competencies

  • Detail-oriented with the ability to manage multiple priorities.
  • Strong communication, analytical, and leadership skills.
  • Strong interpersonal and collaboration skills.
  • Self-driven, proactive, and takes initiative.
  • Ability to self-manage and lead initiatives while working in close collaboration with relevant teams.
  • Strong training and communication skills to promote knowledge-sharing across teams and the research organization.
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