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Lead Compliance Auditor

2 months ago

North Chicago, Illinois, United States Abbott Full time

About Abbott

Abbott is a prominent global healthcare organization dedicated to enhancing the quality of life for individuals at every stage. Our extensive range of transformative technologies encompasses 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.

Working at Abbott

At Abbott, you have the opportunity to engage in meaningful work, advance your career, prioritize your well-being, and embrace your authentic self. Our offerings include:

  • Career growth opportunities within an international company.
  • Comprehensive medical coverage for employees through the Health Investment Plan (HIP) PPO.
  • A robust retirement savings plan with significant employer contributions.
  • Tuition reimbursement and programs to assist with student debt, facilitating your pursuit of higher education.
  • A company consistently recognized as a top employer globally, celebrated for its commitment to diversity and inclusion.

The Role

This position is integral to our corporate compliance audit function, which conducts thorough evaluations of Quality Systems across all Abbott manufacturing facilities. The implications of product quality and regulatory compliance are critical, impacting consumer health, corporate reputation, and market performance.

As a Senior Global Compliance Auditor, you will spearhead Quality System audits and assessments in alignment with regulatory standards and Abbott protocols. Your role will involve collaboration across divisions to synthesize insights from compliance audits and regulatory trends.

Key Responsibilities

  • Independently design, implement, and manage audit policies and programs across divisions.
  • Lead comprehensive audits at Abbott manufacturing sites.
  • Prepare detailed audit reports for executive leadership.
  • Effectively communicate risks and their potential impacts to all management levels.
  • Deliver professional training on compliance and quality issues relevant to Abbott's operations.
  • Develop a risk-based audit strategy.
  • Travel may be required, both domestically and internationally, up to 50% of the time.

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.
  • Excellent time management skills.

Preferred:

  • 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 is a plus.
  • One to two years of experience in Compliance or Regulatory Affairs is desirable.

Abbott is an Equal Opportunity Employer, committed to fostering a diverse workforce. We provide reasonable accommodations to qualified individuals with disabilities.