IT Quality Advisor
Position Title: IT Quality Advisor
Reporting to: Director, Regulatory and Compliance Services
Position Summary: The IT Quality Advisor is a mid-level technical position that reports to the Director, Regulatory and Compliance Services.
The IT Quality Advisor is responsible for understanding software and equipment validation in a government regulated environment with special attention to the Software Development Lifecycle (SDLC) validation processes which meet regulatory expectations and enables clients to effectively work with vendors who are qualified and capable of supporting the clinical and commercial activities. The IT Quality Advisor will provide support to Senior Validation Advisors in all areas of IT Software and Equipment Validation activities. The IT Quality Advisor will work with internal staff in implementation of improved capabilities in the areas of documentation, coding and validation, will assist in performing analysis of current validation situations, review internal controls, create policies and procedures to ensure validation with applicable State and Federal guidelines and policies, and will respond promptly to external and internal concerns; implementing corrective actions as appropriate.
The IT Quality Advisor will be familiar with IT software and equipment validation regulatory expectations. Attention to detail is expected to ensure high quality documentation.
The position requires a high level of integrity as this person is working on a client’s project and preparing documents that may be submitted to regulatory agencies (FDA, EMEA) as needed, and actions impact the quality and reliability of the client’s products.
- Assess client’s current validation processes
- Perform risk assessments on current client’s validation processes
- Propose validation improvement suggestions
- Compose and document validation strategies; Validation Plans, Risk Assessments, Traceability Matrices, Roles & Responsibilities, and other validation documents as needed
- Compose training files and facilitate validation training courses for client employees and consultants
- Provide training on validation SOPs.
- Review documentation for accuracy and completeness
- Bachelor’s degree in a scientific field
- Science or Legal background would be helpful
- Other advanced degree in science (MS or PhD) would be helpful
- Strong problem solving and communication skills
- Broad knowledge of SDLC systems
- Working knowledge of how to effectively perform software validation in an FDA regulated environment
- Excellent project management skills
- Strong interpersonal skills
- High sense of integrity
- Entrepreneurial spirit