Manager Documentation Services

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio spans diagnostics, medical devices, nutritionals, and branded generic medicines, serving people in more than 160 countries.

About the role

This position is based in Lake Forest, IL, within the Core Lab of the Diagnostics Division. The Manager, Documentation Services leads documentation management activities that support new product development and manufacturing operations, overseeing document control, change management, design and drafting, and technical publications while ensuring compliance with FDA, GMP, ISO, and other global regulatory requirements.

Responsibilities

• Manage daily department activities by establishing priorities, work schedules, problem solving, and customer service.
• Set and monitor goals, driving continuous process improvement.
• Ensure employee compliance with Abbott and Division policies.
• Define and allocate resources to meet established project schedules.
• Exercise judgment in planning and organizing work; monitor performance and report status.
• Develop and control the department budget.
• Ensure documentation activities comply with ISO and 21 CFR 820 Quality System Regulation.
• Develop process flows to coordinate documentation change‑control activities between facilities globally.
• Conduct research for the Legal Department during litigation.
• Maintain and control the Device Master Record.
• Provide documents and history records for Device Master Records during regulatory audits.
• Troubleshoot, resolve, and facilitate resolution of problems, identifying causes to prevent recurrence.
• Hire, retain, and develop a diverse, highly qualified staff, providing ongoing performance feedback.
• Maintain a safe and professional work environment.
• Comply with FDA regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments.
• Maintain positive, cooperative communications and collaboration with employees, customers, contractors, and vendors at all levels.

Required Qualifications

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

Preferred Qualifications

• 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.
• Ability to work in a highly matrixed and geographically diverse business environment.
• Strong leadership skills, including the ability to set goals and provide positive, constructive feedback respectfully to build relationships and improve business results.
• Ability to work effectively within a team in a fast‑paced, changing environment.
• Multi‑tasking, prioritizing, and meeting deadlines in a timely manner.
• Strong organizational, planning, and follow‑up skills with the ability to hold others accountable.

Benefits

• Career development with an international company.
• Free medical coverage in the Health Investment Plan (HIP) PPO medical plan (eligible in the next calendar year).
• Excellent retirement savings plan with a high employer contribution.
• Tuition reimbursement, Freedom 2 Save student‑debt program, and FreeU education benefit for obtaining a bachelor’s degree.
• Recognition as a great place to work in dozens of countries and named one of the most admired companies by Fortune.
• Recognition as one of the best large companies for diversity, working mothers, female executives, and scientists.

Pay

The base pay for this position is $99,300.00 – $198,700.00. In specific locations, the pay range may vary from the range posted.