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Senior Global Compliance Auditor

4 months ago

Green Oaks, United States Abbott Full time

The Opportunity

This position works out of our corporate Abbott Park, Illinois location. The Abbott Quality and Regulatory (AQR) Global compliance audit function is a corporate program which conducts audits of Quality Systems across all of Abbotts Manufacturing sites.
 

Product quality and/or regulatory problems can negatively affect consumer health and safety, Abbott’s worldwide image, performance of Abbott earnings and market share and customer confidence and loyalty. The role has a broad responsibility that has significant impact throughout AQR and all divisions. The position is responsible for ensuring executive management is aware of compliance business risks and regulatory requirements.
 

As a Senior Global Compliance Auditor, you will lead Quality System audits and assessments according to regulations, standards, and Abbott procedures. You will participate in cross-divisional activities to integrate information from compliance audits, assessments and regulatory trends that may impact Divisions.
 

The responsibility of the role includes proactive determination of regulatory, compliance, and quality issues, to integrate them into audits and assessments.

The role requires very effective communication and decision making with all levels of management as well as other division and corporate departments. The incumbent must be able to work independently without direct supervision or guidance and to exercise judgment in determining when complex issues merit Corporate Management involvement. Decisions must be made based on up-to-date regulatory knowledge, technical/business knowledge and skills.


What You’ll Work On

Work independently to direct, plan, develop and implement audit policies and programs for systems division-wide Lead audits across Abbott manufacturing sites Write professional audit reports for executive management Communicate effectively to articulate risks and associated impact to all levels of management Develop and provide professional education on compliance and quality topics that are key to Abbott businesses Develop risk-based audit program The role involves up to 50% domestic and international travel.

Required Qualifications

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

Preferred Qualifications

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

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