Documentation & EDM Operations Manager

Abbott; Chicago (IL); On-site; USD 99,000 - 199,000; Full time

Benefits offered by this job

Free medical coverage

Strong retirement match

Tuition reimbursement

Education benefit

Job summary

Abbott is seeking a Manager Documentation Services for the Lake Forest, IL Core Lab, to lead and execute documentation management supporting new product development and manufacturing.

You will oversee document control, change management, design and drafting, and publications to comply with FDA, GMP, ISO, and global regulations, while driving continuous improvement and operational excellence with Quality, Manufacturing, Development, and Legal teams.

Qualifications

• Bachelor’s degree in Engineering, Science, or related field.
• 10+ years progressively responsible documentation management experience.
• Strong leadership skills to manage a department.

Responsibilities

• Manage daily department activities and set priorities.
• Ensure employee compliance with Abbott and Division policies.
• Define and allocate resources to meet project schedules.
• Exercise judgment in planning and organizing work; monitor performance and report status.
• Develop and control department budget.
• Ensure documentation activities meet ISO and 21 CFR 820 requirements.
• Coordinate documentation change control across facilities globally.
• Provide documents and history records for regulatory audits.

Skills

Leadership experience

Documentation management

Regulatory compliance

Project coordination

Education

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

Tools

EDM software

Document control systems

Job description

Abbott is seeking a Manager Documentation Services for the Lake Forest, IL Core Lab, to lead and execute documentation management supporting new product development and manufacturing.

You will oversee document control, change management, design and drafting, and publications to comply with FDA, GMP, ISO, and global regulations, while driving continuous improvement and operational excellence with Quality, Manufacturing, Development, and Legal teams.