Manager Documentation Services

Abbott (abbottcareers2 board); Lake Forest (IL); On-site; USD 105,000 - 150,000; Full time

Benefits offered by this job

Free medical coverage in HIP PPO

Excellent retirement savings plan

Tuition reimbursement

FreeU education benefit

Job summary

Abbott is seeking a Manager Documentation Services in Lake Forest, IL, to lead the documentation team within the Core Lab of Diagnostics. The role focuses on governing document control, change management, and technical publications under FDA, GMP, ISO standards while implementing EDM programs.

You will partner with Quality, Manufacturing, Development, and Legal to drive compliant documentation practices and operational excellence across manufacturing and product development.

Qualifications

• Bachelor's degree in Engineering, Science, or a related field or equivalent experience.
• Minimum 10 years in documentation management with experience in NPI, drafting and electronic data management.
• Strong leadership skills required for this management role.

Responsibilities

• Oversee daily department activities, set priorities, schedules, and drive continuous process improvement.
• Define resources and budgets to meet project schedules; monitor performance and status.
• Ensure compliance with ISO and 21CFR 820 Quality System Regulation.
• Coordinate documentation change control across facilities globally.
• Maintain Device Master Record and provide audit-ready documentation history.

Skills

Leadership

Delegation

Resource planning

Problem solving

Team building

Customer service

Budget management

Education

Bachelor's degree in Engineering/Science or related field

Tools

EDM program

Job description

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 122,000 colleagues serve people in more than 160 countries.

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, 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.
• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with a 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 worldwide 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 the best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

This position works out of our Lake Forest, IL location in the Core Lab , Diagnostics Division. 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.

Manager Documentation Services

The Manager Documentation Services is responsible for leading and executing documentation management activities that support new product development and manufacturing operations. Oversees document control, change management, design and drafting, and technical publications while ensuring compliance with FDA, GMP, ISO, and other global regulatory requirements. Serves as a key leader in the implementation and maintenance of the Electronic Document Management (EDM) program, coordinates documentation efforts for new product introductions, and provides support to division-wide documentation systems. Partners closely with Quality, Manufacturing, Development, and Legal teams to drive compliant documentation practices, operational excellence, and successful business outcomes.

What You'll Work On

• Manages the daily activities of the department by establishing priorities, work schedules, problem solving, and customer service. Setting goals ensures that they are met and are responsible for continuous process improvement. Ensures employee compliance with Abbott and Division policies.
• Defines and allocates resources needed to meet established project schedules. Exercises judgment in planning and organizing work; monitors performance and reports status- Develops and controls department budget.
• Ensures documentation activities are in compliance to ISO and 21CFR 820 Quality System Regulation.
• Developing process flows to coordinate documentation change control activities between facilities in the globally.
• Conducts research for Legal Department during litigation.
• Responsible for maintenance and control of Device Master Record.
• Provides documents and history records regarding Device Master Records during regulatory audits.
• Troubleshoots, resolves, and/or facilitates resolution of problems including identifying causes to prevent re-occurrence.
• Hires and retains a diverse, highly qualified staff and provides ongoing performance feedback. Maintains a safe and professional work environment.
• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

Required Qualifications

• Bachelors degree in Engineering, Science, or a related field, or an equivalent combination of education and work experience.
• Minimum 10 years progressively more responsible documentation management experience including broad knowledge in the field of new product introduction, drafting and electronic data management is required.
• Requires highly developed leadership skills/experience sufficient to assume the responsibilities of this management position.

Preferred Qualifications

• Must be skilled at delegation, follow-up, database management tools, document control procedures, and team building Experience working in a broader enterprise/cross division business unit model preferred.
• Ability to work in a highly matrixed and geographically diverse business environment.
• Strong leadership skills, including the ability to set goals and provide positive and constructive feedback respectfully to build positive relationships and improve business results.
• Abili