Sr. Compliance Auditor I

Abbott; Green Oaks (IL); On-site; USD 111,000 - 223,000; Full time

Job summary

Ein innovatives Unternehmen sucht einen Senior Global Compliance Auditor, um Qualitätssystem-Audits durchzuführen und sicherzustellen, dass alle regulatorischen Anforderungen erfüllt werden. Diese Rolle bietet die Möglichkeit, an der Schnittstelle von Qualität und Compliance zu arbeiten und einen direkten Einfluss auf die Unternehmensstrategie zu haben. Mit einem starken Fokus auf Kommunikation und Entscheidungsfindung werden Sie eng mit Führungskräften zusammenarbeiten, um Risiken zu identifizieren und Lösungen zu entwickeln. Wenn Sie eine Leidenschaft für Qualitätssicherung haben und in einem dynamischen Umfeld arbeiten möchten, ist dies die perfekte Gelegenheit für Sie.

Benefits

Kostenlose medizinische Versorgung

Ruhestandsplan mit hohem Arbeitgeberbeitrag

Tuition Reimbursement

Freiwillige Schuldenreduzierungsprogramme

Ausgezeichnete Arbeitsplatzkultur

Qualifications

• 4 Jahre Erfahrung in Qualitätssicherung oder Engineering in der pharmazeutischen Industrie.
• Zertifizierung als Lead Auditor für Qualitätssysteme erforderlich.

Responsibilities

• Leitung und Durchführung von Qualitätssystem-Audits an Produktionsstandorten.
• Entwicklung und Durchführung von Schulungen zu Compliance- und Qualitätsthemen.

Skills

Kommunikationsfähigkeiten

Kritisches Denken

Entscheidungsfindung

Zeitmanagement

Education

Bachelor-Abschluss in einem wissenschaftlichen oder technischen Bereich

Lead Auditor Zertifizierung

Job description

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals, and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.

Job Description:

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You’ll also have access to:

• Career development with an international company where you can grow the career you dream of.
• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with high employer contribution.
• Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit — an affordable and convenient path to getting a bachelor’s degree.
• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for, as well as a best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

This position is based at our corporate Abbott Park, Illinois location. The Abbott Quality and Regulatory (AQR) Global compliance audit function is a corporate program that conducts audits of Quality Systems across all of Abbott’s manufacturing sites.

Product quality and regulatory issues can negatively impact consumer health and safety, Abbott’s global image, financial performance, market share, and customer loyalty. This role has broad responsibilities with significant impact across AQR and all divisions. It involves ensuring executive management is aware of compliance risks and regulatory requirements.

As a Senior Global Compliance Auditor, you will lead Quality System audits and assessments in accordance with regulations, standards, and Abbott procedures. You will participate in cross-divisional activities to integrate information from audits, assessments, and regulatory trends impacting divisions.

The role includes proactively identifying regulatory, compliance, and quality issues, and integrating them into audits and assessments.

Effective communication and decision-making with all management levels and other departments are essential. The incumbent must work independently without direct supervision, exercising judgment to escalate complex issues to corporate management when necessary, based on current regulatory knowledge, technical expertise, and business understanding.

What You’ll Work On

• Independently direct, plan, develop, and implement audit policies and programs across the systems division.
• Lead comprehensive system audits at Abbott manufacturing sites.
• Draft professional audit reports for executive management.
• Effectively communicate risks and their impacts to all management levels.
• Develop and deliver training on compliance and quality topics relevant to Abbott’s business.
• Develop risk-based audit programs.

Required Qualifications

• Four-year degree in a scientific, technical, or compliance discipline or equivalent experience.
• Lead auditor certification for Quality System audits.
• Strong communication, critical thinking, and decision-making skills.
• Effective time management skills.

Preferred Qualifications

• 8+ years in Quality Assurance or Engineering within the pharmaceutical, device, or nutritional industry.
• Experience with design controls and validations is desirable.
• Experience in product software development and management, including apps, is desirable.
• One or two years in Compliance or Regulatory Affairs is desirable.

*Participants who complete a short wellness assessment qualify for free coverage in our HIP PPO medical plan in the following calendar year.

Learn more about our health and wellness benefits at www.abbottbenefits.com.

Follow your career aspirations to Abbott for diverse opportunities that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott, and on Twitter @AbbottNews and @AbbottGlobal.

The base pay for this position is: $111,300.00 – $222,700.00

In specific locations, the pay range may vary from the range posted.

Job Family:

Operations Quality

Division:

AQR Abbott Quality and Regulatory

Location:

United States > Abbott Park : AP52

Additional Locations:

Work Shift:

Standard

Travel:

Yes, 50% of the Time

Medical Surveillance:

No

Significant Work Activities:

Continuous sitting for prolonged periods (more than 2 hours in an 8-hour day), keyboard use (50% or more of the workday). Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans. EEO is the Law links in English and Spanish.