Site Quality Lead

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 113,000 colleagues serve people in more than 160 countries.

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 109,000 colleagues serve people in more than 160 countries.

Diagnostic testing is a compass, providing information that helps in the prevention, diagnosis and treatment of a range of health conditions. 

Abbott’s life-changing tests and diagnostic tools give you accurate, timely information to better manage your health. We’re empowering smarter medical and economic decision making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott’s diagnostics instruments, providing lab results for millions of people.

Our location in Richmond, VA currently has an opportunity for a Site Quality Lead.  In this role, you will be responsible for identifying, leading, and/or supporting quality, regulatory, and compliance improvement initiatives, projects, and remediation activities that support Toxicology business entity activities. This position will focus on implementing and maintaining effective document control and training compliance, building and maintaining alignment of quality and operational processes to corporate and division policies and applicable regulations, and deploying these Quality System processes to one or more entities. This job description will be reviewed periodically and is subject to change by management.

WHAT YOU’LL DO:

• Supports the development, implementation, improvement and/or effectiveness of Quality Systems in compliance with applicable ISO, FDA and other regulatory agency regulations and standards through implementation of effective Quality System programs.

• Uses skills to establish and manage an effective document and change control process for the assigned business entity, and may include the deployment of shared processes across various Toxicology entities.

• Acts as a site Subject Matter Expert in Quality System areas such as Document Control, Management Review, Quality Metrics, and training administration while sharing knowledge through best practices and risk mitigation strategies.

• Manages assigned data collection, performance metrics, evaluation, analysis and scientific writing of reports results to site and/or Business Unit leadership.  Provides, and may execute, suggested remediation activities.

• Works directly with entities in establishing compliant Quality System processes and programs.

• Leads or assists internal and external audits as assigned.

• Understands and is aware of the quality consequences which may occur from the improper performance of their specific job; has awareness of the impact of testing best practices on testing outcomes and confidence in testing veracity.

• Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices; build productive internal/external working relationships.

EDUCATION AND EXPERIENCE YOU’LL BRING

Required

• Bachelor’s degree or related equivalent experience.

• Minimum of 5 years of experience in Quality Assurance activities in a medical device or pharmaceutical industries, or within a related industry or role with exposure to quality practices and quality processes. 

• Prior supervisory or management experience with responsibility for project delivery.

• Industry experience in managing document control processes and software.

• Experience managing or supporting a quality system training program.

• Thorough knowledge and practical application of Quality System Regulations or other applicable regulatory area or standard scheme.

• Ability to articulate complex quality and regulatory matters with persons of a variety of backgrounds.

• ASQ Certification or equivalent is beneficial.

• Must have capability to review, analyze, summarize and interpret quality systems data, draw conclusions, make appropriate decisions and recommendations, write reports and best practices and give oral presentations.

Preferred

• Master’s degree preferred.

• Strong analytical, written, people-influencing and verbal communication skills.

• Effective organizational and time management skills.

• Must show strong self-initiative and be comfortable in the role of a team player. 

• Must be able to work independently with minimal supervision.

• Prior experience with FDA or related audits.

• Supervisory experience is also preferred.

WHAT WE OFFER

At Abbott, you can have a good job that can grow into a great career. We offer:

• Training and career development, with onboarding programs for new employees and tuition assistance

• Financial security through competitive compensation, incentives and retirement plans

• Health care and well-being programs including medical, dental, vision, wellness and occupational health programs

• Paid time off

• 401(k) retirement savings with a generous company match

• The stability of a company with a record of strong financial performance and history of being actively involved in local communities

Learn more about our benefits that add real value to your life to help you live fully:  http://www.abbottbenefits.com/pages/candidate.aspx

Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.