Documentation Services Manager – Compliance & Process Lead

Abbott Laboratories; Lake Forest (IL); On-site; USD 99,000 - 199,000; Full time

Job summary

Abbott Laboratories in Lake Forest, IL, seeks a Manager of Documentation Services to lead and execute documentation management for new product development and manufacturing operations.

The role oversees document control, change management, drafting, and technical publications, ensuring FDA/ISO compliance and EDM program maintenance while collaborating with Quality, Manufacturing, Development, and Legal teams.

Qualifications

• Bachelor's 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.

Responsibilities

• Manage daily department activities, set priorities, schedules, and address customer service.
• Define resources and plan budgets to meet project schedules.
• Ensure documentation activities comply with ISO and 21CFR 820 quality regulations.
• Coordinate documentation change control across facilities globally.
• Support litigation research for Legal Department.
• Maintain and control Device Master Record and related history records.

Skills

Documentation management

Leadership

Regulatory compliance

Project coordination

Education

Bachelor's degree in Engineering, Science, or related field

10+ years documentation management experience

Job description

Abbott Laboratories in Lake Forest, IL, seeks a Manager of Documentation Services to lead and execute documentation management for new product development and manufacturing operations.

The role oversees document control, change management, drafting, and technical publications, ensuring FDA/ISO compliance and EDM program maintenance while collaborating with Quality, Manufacturing, Development, and Legal teams.