Process Reengineering & Validation Specialist

GAP SOLUTIONS INC; Bethesda (MD); On-site; USD 90,000 - 150,000; Full time

Job summary

GAP Solutions Inc. is seeking an Experienced IT professional for the NIH NIH CIB Enterprise Clinical Informatics Systems validation and assurance. The role emphasizes maintaining regulatory compliance and supporting health authority inspections.

The candidate should have a Bachelor’s Degree and at least six years of relevant experience, with familiarity in FDA/ICH requirements and quality management systems. Day shifts, full-time on-site work in Bethesda, MD are expected.

Qualifications

• Bachelor’s Degree is required.
• Requires six years of relevant experience.
• FDA/ICH knowledge (e.g., 21 CFR Part 11) is preferred.
• Experience with Quality Management Systems is preferred.

Responsibilities

• Perform computer systems validation/assurance activities.
• Update CIB systems to support health authority requirements.
• Develop processes and procedures to support regulatory compliance.
• Support validation/assurance of NIAID CIB Enterprise Clinical Informatics Systems.
• Respond to validation findings and take corrective actions.
• Support health authority inspections.
• Maintain validated state of NIAID CIB Enterprise Clinical Informatics Systems.
• Ensure systems comply with FDA and international requirements for clinical research protocols.
• Manage access privileges for all users of NIAID Enterprise Clinical Informatics Systems per SOP.
• Coordinate between customers and project teams to enable enterprise-wide integration of reengineering efforts.

Skills

Effective communication

Detail oriented

Organizational skills

Regulatory knowledge

Education

Bachelor's Degree

Job description

GAP Solutions Inc. is seeking an Experienced IT professional for the NIH NIH CIB Enterprise Clinical Informatics Systems validation and assurance. The role emphasizes maintaining regulatory compliance and supporting health authority inspections.

The candidate should have a Bachelor’s Degree and at least six years of relevant experience, with familiarity in FDA/ICH requirements and quality management systems. Day shifts, full-time on-site work in Bethesda, MD are expected.