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Lead Compliance Auditor

2 months ago


North Chicago, Illinois, United States Abbott Full time

About Abbott

Abbott is a leading global healthcare organization dedicated to enhancing the quality of life for individuals at every stage of their health journey. Our extensive portfolio encompasses transformative technologies across various healthcare sectors, including diagnostics, medical devices, nutritionals, and branded generic medicines. With a workforce of 114,000 professionals, we serve communities in over 160 countries.

Why Work at Abbott?

At Abbott, you will engage in meaningful work, pursue personal and professional growth, and enjoy a balanced life. Our employees benefit from:

  • Career advancement opportunities within a global organization.
  • Comprehensive medical coverage for employees through the Health Investment Plan (HIP) PPO.
  • A robust retirement savings plan with substantial employer contributions.
  • Tuition reimbursement and programs designed to alleviate student debt, facilitating access to higher education.
  • A workplace recognized for its commitment to diversity and inclusion, consistently ranked among the best in various categories by Fortune.

Position Overview

This role is integral to our corporate compliance audit function, focusing on the assessment of Quality Systems across Abbott's manufacturing facilities. The Senior Global Compliance Auditor will play a crucial role in identifying compliance risks and regulatory obligations, ensuring that executive management is informed of potential business impacts.

Key Responsibilities

  • Independently lead and manage audits of Quality Systems in accordance with applicable regulations and Abbott's internal procedures.
  • Prepare comprehensive audit reports for senior management, clearly communicating risks and their implications.
  • Collaborate across divisions to synthesize findings from compliance audits and assess regulatory trends affecting the organization.
  • Proactively identify and address compliance and quality issues, integrating them into audit strategies.
  • Facilitate professional development sessions on compliance and quality matters relevant to Abbott's operations.
  • Manage a risk-based audit program and undertake domestic and international travel as required.

Qualifications

Required:

  • Bachelor's degree in a scientific, technical, or compliance-related field, or equivalent experience.
  • Certification as a lead auditor for Quality System audits.
  • Strong communication, critical thinking, and decision-making abilities.
  • Effective time management skills.

Preferred:

  • 8+ years of experience in Quality Assurance or Engineering within the pharmaceutical, device, or nutritional sectors.
  • Familiarity with design controls and validations.
  • Experience in product software development and management.
  • 1-2 years of experience in Compliance or Regulatory Affairs.

Abbott is committed to fostering a diverse workforce and provides reasonable accommodations for qualified individuals with disabilities.