Manager, Quality Manager - CAPA

Abbott•Columbus, IL

52d•Onsite

About The Position

The Quality Manager, CAPA provides corporate-level leadership and guidance for Quality Systems matters related to nonconformance, investigation, and Corrective And Preventive Action (CAPA) processes, as well as other related Abbott Quality System elements. This includes providing support, quality and technical expertise, and consulting activities globally to Abbott Businesses/Divisions. The incumbent must possess a working knowledge of global regulations and industry standards pertinent to nonconformance, investigation, and CAPA processes. A strong understanding of the relationship between CAPA and other Quality System elements, such as management responsibility, risk management, complaint management, design controls, and validation, is also required. This role is based out of Abbott Park, Illinois.

Requirements

Bachelor’s Degree in Life or Engineering Sciences discipline (preferred).
Overall 10+ years of experience.
6 years of experience in nonconformance and CAPA processes, root cause analysis tools, and quality system continuous improvement in a regulated industry.
4 years in Quality Assurance and/or Compliance, in a managerial, supervisory, or SME role.
10+ years in a professional-level position within the Medical Device, Pharmaceutical, and/or Nutritional industry.
3 years of project management experience (certification is preferred but not required).
10-12 years total combined minimum years of industry experience.

Responsibilities

Use established management skills to lead global committees and teams to achieve quality systems objectives, including training, evaluating the effectiveness of business application of nonconformance/CAPA processes, and implementing necessary requirements into the corporate-wide quality management system, regulatory compliance, and business objectives.
Act as the corporate liaison to Abbott Businesses/Divisions, providing expert support in the subject matter of nonconformance, investigation, and CAPA elements.
Remain current on regulatory requirements, best practices, and regulatory agency expectations to drive updates in corporate policies and procedures.
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 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, and continuous improvement initiatives.
Manage multiple global projects, particularly in nonconformance, investigation, and corrective and preventive action, including leadership of the Nonconformance and CAPA community of practice (CoP).
Provide active leadership, participation, and analysis of nonconformance and CAPA quality data and assessments.
Manage confidential information across the project lifecycle.
Interact significantly with executive management with accountability for assigned projects.