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Lead Compliance Auditor

2 months ago

North Chicago, Illinois, United States Abbott Laboratories company Full time

About Abbott Laboratories

Abbott Laboratories is a leading entity in the healthcare sector, dedicated to enhancing the quality of life for individuals at every stage. Our extensive range of innovative technologies encompasses diagnostics, medical devices, nutritional products, 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, experience personal and professional growth, and enjoy a balanced life. Our employees benefit from:

  • Opportunities for career advancement within a global organization.
  • Comprehensive medical coverage for employees through the Health Investment Plan (HIP) PPO.
  • A robust retirement savings plan with significant employer contributions.
  • Tuition reimbursement, student debt relief programs, and educational benefits for pursuing a bachelor's degree.
  • A company recognized globally as a top employer and one of the most admired organizations by Fortune.
  • A workplace celebrated for its commitment to diversity and inclusion.

The Role

This position is integral to our corporate compliance audit function, which evaluates Quality Systems across all Abbott manufacturing facilities. The role is pivotal in identifying and mitigating compliance risks that could impact consumer health, corporate reputation, and market performance.

As a Senior Global Compliance Auditor, you will spearhead Quality System audits and assessments in accordance with regulatory standards and Abbott protocols. You will collaborate across divisions to synthesize insights from compliance audits and regulatory trends that may influence various sectors.

Key Responsibilities

  • Independently direct, plan, and implement audit policies and programs across the organization.
  • Conduct audits at Abbott manufacturing sites.
  • Prepare detailed audit reports for executive leadership.
  • Effectively communicate risks and their implications to all management levels.
  • Provide professional training on compliance and quality issues critical to Abbott's operations.
  • Develop a risk-based audit strategy.
  • Travel domestically and internationally as required, up to 50% of the time.

Required Qualifications

  • 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.
  • Proficient time management skills.

Preferred Qualifications

  • Over 8 years of experience in Quality Assurance or Engineering within the pharmaceutical, device, or nutritional sectors.
  • Experience with design controls and validations is advantageous.
  • Familiarity with product software development and management, including applications, is a plus.
  • One to two years of experience in Compliance or Regulatory Affairs is preferred.

Health and Wellness Benefits

Employees who complete a wellness assessment are eligible for complimentary coverage in our HIP PPO medical plan for the following calendar year.

Join Abbott for a fulfilling career that supports your aspirations and promotes a balanced lifestyle. Abbott is an Equal Opportunity Employer, committed to fostering a diverse workforce.