Manager, Quality Manager - CAPA

Abbott; Illinois; On-site; USD 129,300 - 258,700; Full time

Benefits offered by this job

Free medical coverage

Excellent retirement savings plan

Tuition reimbursement

Flexible career development

Job summary

Abbott is seeking a Quality Manager, CAPA, to provide leadership for its Quality Systems. This role includes managing global projects related to nonconformance and CAPA processes, ensuring compliance with regulatory standards, and enhancing Abbott's overall quality management system.

The ideal candidate will have a strong background in quality assurance, project management, and experience in a regulated industry. The position offers a salary range from $129,300.00 to $258,700.00.

Qualifications

• 10+ years of experience in a regulated industry.
• 6+ years in nonconformance and CAPA processes.
• 4 years in a managerial or supervisory role.

Responsibilities

• Lead global committees to achieve quality systems objectives.
• Act as a corporate liaison for nonconformance and CAPA support.
• Monitor and analyze quality data to improve Abbott’s Quality Systems.

Skills

Nonconformance processes

Corrective and Preventive Action (CAPA)

Root cause analysis tools

Quality Assurance

Project management

Education

Bachelor’s Degree in Life or Engineering Sciences

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 115,000 colleagues serve people in more than 160 countries.

Quality Manager, CAPA

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be yourself 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.
• 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 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

The function of the Quality Manager, CAPA is to provide corporate-level leadership and guidance for Quality Systems matters related to nonconformance, investigation and Corrective and Preventive Action (CAPA) processes and other related Abbott Quality System elements. This includes Business/Division support, quality and technical expertise and consulting 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 have working knowledge and understand the relationship to other related Quality System elements, e.g., management responsibility, risk management, complaint management, design controls, validation, etc.

This role will be based out of Abbott Park, Il.

What You’ll Work On

• Use established management skills to lead global committees and teams to achieve quality systems objectives, inclusive of training, evaluation of effectiveness of business application of the nonconformance/CAPA processes and implementation of necessary requirements into the corporate wide quality management system, 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 nonconformance, investigation and CA/PA elements.
• 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 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, continuous improvement initiatives, etc.
• The scope of this position is Abbott-wide, covering all Abbott Businesses / Divisions.
• This position manages multiple global projects, particularly in nonconformance, investigation, corrective and preventive action including leadership of the Nonconformance and CAPA community of practice (CoP).
• Active leadership and participation and analysis of nonconformance and CAPA quality data and 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 Degree required; Life or Engineering Sciences discipline, preferred.
• Overall 10+ years of experience with 6 years in nonconformance and CAPA processes, root cause analysis tools, quality system continuous improvement experience in a regulated industry required.
• 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 is preferred but not required).
• 10-12 years (not necessarily the sum of the above) Total combined minimum years of industry experience required.

Abbott is an Equal Opportunity Employer, committed to employee diversity.

The base pay for this position is $129,300.00 – $258,700.00. In specific locations, the pay range may vary from the range posted.