JOB DESCRIPTION:
Quality Manager, CAPA
Working at Abbott
At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life.You’llalso have access to:
- Career development with an international company where you can grow the career you dream of.
- Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
- An excellent retirement savings plan with high employer contribution
- Tuition reimbursement, the _Freedom 2 Save_ student debtprogramand _FreeU_ education benefit - an affordable and convenient path to getting a bachelor’s degree.
- A company recognized asa great placeto 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
The function of the Quality Manager, CAPA is to provide corporate-level leadership and guidance for Quality Systems matters related tononconformance, investigation and Corrective And Preventive Action (CAPA) processes and other related Abbott Quality System elements. This includes Business/Division support, quality and technicalexpertiseandconsulting activities globally. The incumbent must have a working knowledge of global regulations and industry standards related to nonconformance, investigation, and Corrective And Preventive Action (CAPA) processes. The incumbent should also haveworkingknowledge and understand the relationship to other related Quality System elements, e.g., management responsibility, risk management, complaint management, design controls, validation, etc.
This rolewillbe based out ofAbbott Park, I _l_
What You'll Work On
- Use established management skills to lead global committees and teams to achieve qualitysystems objectives,inclusive of training, evaluation of effectiveness of business application of the nonconformance/CAPAprocesses andimplementation of necessary requirements into the corporate wide quality management system,regulatory compliance, and businessobjectives.
- Act as the corporate liaison to Abbott Businesses/Divisions and provide support as an expert in the subject matter ofnonconformance, investigation and CA/PA elements.
- Remain current on regulatory requirements, best practices, and regulatory agency expectations to drive updates in corporate policies and procedures asappropriate.
- Participate in industry groups related to the subjectmatterareas of responsibility.
- Improve the effectiveness of Abbott’s Quality Systems through monitoring,trendingandanalyzingquality data and industry intelligence information.
- Act as a change agent for incorporating best practice methods through business support activities such as remediation, training, coaching,continuous improvement initiatives,etc.
- The scope of this position is Abbott-wide, covering all Abbott Businesses /Divisions.
- This position manages multiple global projects, particularlyinnonconformance, investigation,corrective andpreventive action including leadership of the Nonconformance and CAPA community of practice (CoP).
- Active leadership and participationand analysis of nonconformance and CAPA quality dataand assessments.
- 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.
Required Qualifications
- Bachelor’s Degreerequired; Life or Engineering Sciences discipline, preferred.
- Overall10+ years of experience with 6 years innonconformance and CAPAprocesses, root cause analysis tools,quality systemcontinuous improvementexperience in a regulated industryrequired.
- 4 years in Quality Assurance and/or Compliance, managerial, supervisory or SME role;10+ years in Medical Device, Pharmaceutical and/or Nutritional industry professional-level position.
- 3 years of project management experience (certification ispreferred butnotrequired).
- 10-12 years (not necessarily the sum of the above)Total combined minimum years of industry experiencerequired.
