Abbott

Manager, Quality Manager - CAPA

Abbott • $129K — $258K *
Columbus, OH 43230In-Person
Pharmaceuticals & Biotech
8 - 10 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Bachelor’s Degree required; Life or Engineering Sciences preferred.
  • 10+ years of experience in regulated industry, with 6 years focused on nonconformance and CAPA processes.
  • 4 years in Quality Assurance, managerial or supervisory role; experience in Medical Device, Pharmaceutical, or Nutritional industry.
  • 3 years of project management experience; certification preferred.
  • Total combined industry experience of 10-12 years required.

Responsibilities

  • Lead global teams to achieve quality system objectives related to CAPA processes and regulatory compliance.
  • Act as a corporate liaison and subject matter expert for nonconformance and CAPA elements.
  • Stay updated on regulatory requirements to inform updates in corporate policies and procedures.
  • Engage with industry groups to share insights and best practices in quality management.
  • Monitor and analyze quality data to improve Abbott’s Quality Systems effectiveness.
  • Act as a change agent in implementing best practices through training and coaching initiatives.
  • Manage multiple global projects in nonconformance and CAPA, leading community practices.

Benefits

  • Health and wellness benefits to support your family.
  • Diverse opportunities for career growth within the company.
  • Flexible working arrangements with the potential for travel.
  • Support for continuous improvement and professional development.
Full Job Description
Quality Manager, CAPA 
  

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.  

 

Apply Now 

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: https://abbottbenefits.com/ 

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life.

Connect with us at abbott.com, on LinkedIn at https://www.linkedin.com/company/abbott-/, and on Facebook at https://www.facebook.com/AbbottCareers. 

 

     

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.

     

JOB FAMILY:Operations Quality

     

DIVISION:AQR Abbott Quality and Regulatory

        

LOCATION:United States > Abbott Park : AP52

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:Standard

     

TRAVEL:Yes, 50 % of the Time

     

MEDICAL SURVEILLANCE:No

     

SIGNIFICANT WORK ACTIVITIES:Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)

     

About Abbott

Abbott Careers

Joining Abbott means becoming part of a globally diverse team dedicated to making a lasting impact on human health. As a leader in healthcare innovation, Abbott provides a dynamic workplace where careers flourish through growth, leadership, and diversity training.

Opportunities at Abbott

Explore a world of opportunities with our team. Whether you're seeking job opportunities in engineering, marketing, research, or healthcare, Abbott offers a variety of positions that allow professionals to grow their careers. Our commitment to diversity and innovation is evident in every aspect of our work, fostering an inclusive culture that values each team member's contribution.

Work You'll Do

At Abbott, every role contributes to our mission of helping people live fuller lives through better health. From groundbreaking research in medical devices to advancements in pharmaceuticals, our team is at the forefront of healthcare innovation. By joining Abbott, you are not just accepting a job; you are embarking on a path of professional and personal growth.

Internship Programs

Kickstart your career with an Abbott internship. Our programs provide invaluable industry experience and a chance to develop essential skills in a real-world setting. Interns at Abbott work on projects that matter, gaining the experience and knowledge necessary to succeed in their future careers.

Professional Development

Abbott is dedicated to the continuous professional development of its employees. With access to cutting-edge technology, leadership programs, and diversity training, our team members are equipped to lead and innovate within the healthcare industry. We support your career journey with robust training programs, mentorship, and opportunities for networking and professional growth.

Benefits and Culture

Our employees enjoy comprehensive benefits designed to support their life and well-being. From health insurance to retirement plans, we ensure our team has everything they need to thrive. Abbott's culture is built on a foundation of respect and integrity, united by a shared commitment to improving health outcomes.

Join Our Team

Discover the impact you can make with a career at Abbott. We are hiring individuals who are passionate, curious, and driven to lead. Search open positions that match your skills and interests on our Jobs page. Prepare your resume, sharpen your interview skills, and get ready to join a team that's at the cutting edge of healthcare solutions.

Stay Connected

Keep up to date with career tips, industry insights, and company news—all from the people who work here. Subscribe to our Careers Blog and personalize your subscription to receive job alerts and insider tips tailored to your preferences.

Explore Abbott

With a commitment to improving life through innovation, leadership, and diversity, Abbott is a place where you can fulfill your potential. See what exciting and rewarding opportunities await at Abbott by exploring our career opportunities today.

SEARCH ABBOTT JOBS

Join us in our mission to make the world a healthier place through innovation, leadership, and diversity. Your journey to a fulfilling career at Abbott starts here.
Learn more about Abbott
Size
113,000 employees
Market Cap
$189 billion
Industry
Healthcare
Net Income
$4.4 billion
Founded
1944
5 Year Trend
+15.6%
Revenue
$34.6 billion
NASDAQ
ABT
* Ladders Estimates

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