Director of Documentation & EDM Programs

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

Benefits offered by this job

Free medical coverage

Tuition reimbursement

Retirement plan

Education benefit

Job summary

Abbott Lake Forest IL is seeking a Manager Documentation Services to lead and execute documentation management for new product development and manufacturing. You will oversee document control, change management, design and drafting, and publications to ensure FDA, GMP, ISO compliance and EDM program maintenance.

Collaborate with Quality, Manufacturing, Development and Legal to drive compliant documentation practices, operational excellence, and successful business outcomes in a global, matrixed

Qualifications

• Bachelor's degree in Engineering, Science, or a related field required.
• Minimum 10 years of documentation management experience with new product introduction and electronic data management.
• Demonstrated leadership experience for a management role.

Responsibilities

• Lead and execute documentation management activities supporting new product development and manufacturing operations.
• Oversee document control, change management, design and drafting, and technical publications.
• Ensure compliance with FDA, GMP, ISO and other global regulatory requirements.
• Partner with Quality, Manufacturing, Development and Legal to drive compliant documentation practices and operational excellence.
• Maintain and drive the EDM program implementation and maintenance across divisions.

Skills

Leadership

Documentation management

Budgeting

Regulatory compliance

Cross-functional collaboration

People management

Education

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

Tools

Electronic Document Management (EDM)

Quality management systems

Job description

Abbott Lake Forest IL is seeking a Manager Documentation Services to lead and execute documentation management for new product development and manufacturing. You will oversee document control, change management, design and drafting, and publications to ensure FDA, GMP, ISO compliance and EDM program maintenance.

Collaborate with Quality, Manufacturing, Development and Legal to drive compliant documentation practices, operational excellence, and successful business outcomes in a global, matrixed