SQA Group is a technology and advisory services firm in growth mode, partnering with Fortune 500 companies, large enterprises and mid-market organizations to help our clients craft a culture of continuous transformation. We introduce a blend of emerging technology solutions, data science services, and consulting services to fuel our clients’ modernization initiatives. We help them accelerate to next.
We are seeking a Computer System Validation Lead to coordinate CSV activities across multiple implementations and workstreams. The appropriate consultant would have experience in both the systems/technical space as well as Compliance and Validation. The Validation Lead will be responsible for conducting risk assessments and ensuring change management/control are incorporated as part of the validation strategies.
- Lead the Validation and compliance activities for multiple initiatives
- Coordinate and report on the implementation related activities across workstreams
- Define and lead overall Validation strategy for complex GxP programs
- Author technical specifications such as Requirements, Design, Test scripts
- Coordinate with external Vendors on Validation and general IT operations support tasks
- Monitor and serve IT operational requests on as need basis
Critical Success Factors:
- Experience leading validation and compliance activities across Clinical development systems (Regulatory, Quality, Clinical and other systems)
- Experience developing Validation artifacts: strategies, plans, traceability matrices, summary reports
- Broad understanding of Technology implementation (SaaS) and Data migrations approaches
- Project management skills with experience working on large scale projects
Thank you for your interest in pursuing a career at SQA Group! SQA Group is an equal opportunity employer and supports workforce diversity. This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities above are intended to describe those functions that are essential to the performance of this job. This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. All requirements are subject to possible modification to reasonably accommodate individuals with a disability.