Documentation Services Manager – EDM & Regulatory Compliance

Thornton Tomasetti; Lake Forest, Northern (IL, KY); Hybrid; USD 99,000 - 199,000; Full time

Benefits offered by this job

Free medical coverage

Tuition reimbursement

Retirement savings plan

FreeU education benefit

Job summary

Abbott in Lake Forest, IL, is seeking a Manager Documentation Services to lead documentation management for new product development and manufacturing. You will oversee document control, change management, design and drafting, and technical publications while ensuring FDA, GMP, ISO and other global regulatory compliance.

The role partners with Quality, Manufacturing, Development and Legal to drive compliant documentation practices, and to implement and maintain the Electronic Document Management

Qualifications

• Bachelor's degree in Engineering, Science, or related field.
• Minimum 10 years of documentation management experience in product development and/or manufacturing.
• Strong leadership and cross-functional collaboration skills.
• Experience with EDM and regulatory compliance.

Responsibilities

• Lead daily department activities, set priorities and budgets.
• Ensure compliance with FDA, GMP, ISO.
• Coordinate EDM and cross-facility documentation change control.
• Partner with Quality, Manufacturing, Development and Legal teams.

Skills

Leadership

Strategic planning

Communication

Project management

Education

Bachelor's degree in Engineering/Science

Tools

EDM software

Job description

Abbott in Lake Forest, IL, is seeking a Manager Documentation Services to lead documentation management for new product development and manufacturing. You will oversee document control, change management, design and drafting, and technical publications while ensuring FDA, GMP, ISO and other global regulatory compliance.

The role partners with Quality, Manufacturing, Development and Legal to drive compliant documentation practices, and to implement and maintain the Electronic Document Management