Business Process Reengineering Specialist III (52611)

GAP SOLUTIONS INC; Bethesda (MD); On-site; USD 90,000 - 130,000; Full time

Job summary

GAP Solutions Inc. is seeking an experienced professional for a role focused on Computer Systems Validation/Assurance within NIH CIB Enterprise Clinical Informatics Systems in Bethesda, MD. The position emphasizes regulatory compliance and collaboration with cross-functional teams.

Responsibilities include updating systems for health authority requirements, managing access controls, and supporting inspections while ensuring the validated state of systems and adherence to SOPs.

Qualifications

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

Responsibilities

• Perform Computer Systems Validation/Assurance activities and tasks.
• 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 implement corrective actions.
• Support health authority inspections.
• Maintain validated state of CIB systems and related servers/software.

Skills

Communication skills

Detail-oriented

Organizational skills

Prior FDA/ICH experience

Education

Bachelor's Degree

Job description

Job Details

• Level: Experienced
• Job Location: National Institutes of Health (NIH) - Main Campus/Bethesda - Bethesda, MD 20892
• Position Type: Full Time
• Education Level: Bachelors Degree
• Salary Range: $1.00 - $2.00 Salary/year
• Travel Percentage: None
• Job Shift: Day
• Job Category: Information Technology

Duties and Responsibilities

• Responsible for a variety of Computer Systems Validation/Assurance activities and tasks.
• Updating CIB systems to support health authority requirements.
• Developing processes and procedures to support regulatory compliance requirements.
• Supporting initial and periodic Validation/Assurance of NIAID CIB Enterprise Clinical Informatics Systems.
• Responding to validation findings and taking corrective actions.
• Supporting health authority inspections.
• Conducting activities to maintain the validated state of NIAID CIB Enterprise Clinical Informatics Systems.
• Maintain the Computer Systems Validation/Assurance of the servers and the software to ensure that the systems are compliant.
• Comply with requisite FDA and other applicable international requirements for clinical research protocols.
• Manage and document the access privileges for all users that access the NIAID Enterprise Clinical Informatics Systems in compliance with documented standard operating procedures (SOP), which shall be provided to the Contractor upon award.
• Manage use of process improvement, reengineering methodologies, and internet-related methodologies and principles to conduct process modernization projects.
• Responsible for transitioning of existing organizations or project teams in accomplishing the organization’s goals or project activities and objectives through improved use of internet and other automated processes.
• Support activity and data modeling, development of modern business methods, identification of best practices, and creating and assessing performance measurements.
• Provide group facilitation, interviewing, training, and additional forms of knowledge transfer.
• Serve as key coordinator between customers and multiple project teams to ensure enterprise-wide integration of reengineering efforts and application of best practice including e-business practices.
• May provide daily supervision and direction to other contractor business reengineering specialists and web architects.

Basic Qualifications

• Bachelor’s Degree is required
• Requires six years of relevant experience

Preferred Qualifications

• Ability to communicate effectively, orally and in writing, with non-technical and technical staff
• Detail-oriented and possess strong organizational skills with the ability to prioritize multiple tasks and projects
• Prior experience with Food and Drug Administration (FDA) and International Conference on Harmonization (ICH) requirements, e.g. 21 Code of Federal Regulations (CFR) Part 11 is preferred
• Prior experience working with Quality Management Systems is preferred.

*This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required by this position.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status or other characteristics protected by law.