Manager, Quality Manager - Complaints

Program Quality Manager In Complaints, Vigilance And Product Actions

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.

This position works out of our Abbott Park IL (preferred) or any Abbott's manufacturing location.

The function of the Quality Program Manager is to provide corporate-level leadership and guidance for Quality Systems matters related to complaint management, medical device reporting / vigilance and product actions (corrections and removals), as well as supporting other Abbott Quality System elements as it relates to post market surveillance. This includes but is not limited to providing global support to Abbott Businesses / Divisions, subject matter expertise, training, and consultation on regulatory and compliance strategy and application. The incumbent must have a working knowledge of global regulations and industry standards, especially as the relate to complaint management, recalls, and medical device reporting. The incumbent should also have knowledge of related Quality System elements, e.g., Vigilance Reporting, Risk Management, Nonconformances & CAPA, etc.

Use established management skills to lead global committees and teams to achieve quality, regulatory compliance, and business objectives.

Act as the corporate liaison to Abbott Businesses / Divisions and provide support as an expert in the subject matter of complaints management, product actions, and medical device reporting.

Remain current on regulatory requirements, best practices, and regulatory agency expectations to drive updates in corporate policies and procedures as appropriate.

Participate in industry groups related to the subject matter areas of responsibility.

Improve the effectiveness of Abbott's Quality Systems through monitoring, trending and analyzing of quality data and industry intelligence information.

Act as a change agent for incorporating best practice methods through business support activities such as remediation, training, coaching, etc.

The scope of this position is Abbott-wide, covering all Abbott Businesses / Divisions.

This position manages multiple global projects, particularly in Complaint Management and Product Actions. Active participation in global Adverse Event Reporting projects is also likely.

Given the nature of the projects as they relate to regulatory and quality compliance, the financial consequences for adverse regulatory findings or delayed product approval initiatives can be significant.

This position manages confidential information across the project lifecycle.

This position requires significant interaction with executive management with accountability for assigned projects.

Bachelor's Degree required; Life or Engineering Sciences discipline, preferred.

Overall 10+ years of experience with 6 years in Complaint Management and / or Corrections and removals experience in a regulated industry required.

4 years in Quality Assurance and / or Compliance, managerial, supervisory or SME role; 6+ years in Medical Device, Pharmaceutical and / or Nutritional industry professional-level position.

External regulatory experience in product actions (corrections and removals) or medical device reporting desired