Validation Specialist, Quality and Risk Management:

Cornerstone understands the importance of delivering our SaaS solutions in a quality-oriented manner that meets the regulatory and business expectations of our clients.  This includes Life Sciences, Banking and Financial Services, Manufacturing, Healthcare, Government, etc.  In software engineering, verification and validation (V&V) is the process of checking that a software system meets specifications and that it fulfills its intended purpose.  The Principal V&V Specialist is a critical role for ensuring that Cornerstone meets and demonstrates these processes to our regulated clients.  This role reports to the Head of Quality within the Quality and Risk Management (QRM) organization.   

The Quality and Risk Management team owns the overarching Quality Management System at Cornerstone.  This includes, but is not limited to:

Regulatory expertise, consulting, and oversight to all functional areas within Cornerstone
Audit Management
Learning and Development Management
Document Management
Deviation Management
Quality Plan and CAPA Management
Independent Verification and Validation Management (regulated industry clients).

QRM promotes awareness and provides updates to the IT System Development Life Cycle (SDLC) throughout IT and strives to ensure that the Cornerstone Solution is compliant to the level of quality that consistently meets or exceeds business needs and regulatory requirements.  These responsibilities are further defined in the overall Cornerstone IT Quality Management System (IT QMS) and carried out within the Cornerstone IT Quality Manual. 
The Principal V&V Specialist will be responsible for providing a software V&V package that provides documentary evidence of the verification and validation activities performed during the development, release, and maintenance of the Cornerstone Solution. 

In this role you will...

Work closely with internal teams such as Quality, Product, and Engineering to develop, support, and maintain a software V&V package that demonstrates verification and validation activities for the Cornerstone Solution and is leveraged by clients in regulated industry (e.g., Life Sciences, Banking and Financial Services, Healthcare, Manufacturing, Government, etc.).Involved in the development, implementation, and maintenance of the Verification and Validation Strategy.Perform software verification and validation activities for Enhancements and changes to the Cornerstone Solution, which includes the following:Eliciting functional requirements and specifying these in Software Functional Specifications.Developing test plans and scripts for functional and regression testing and executing tests manually or using automated tools.Conducting QA reviews of system development and release deliverables.Be recognized as a thought leader in regulated industry.  This includes leading and participating in industry forums, SIGs, etc. or maintaining industry certifications.

General Requirements:

Bachelor’s degree in information systems, Computer Science or related discipline is highly desired.Strong working knowledge of tools associated with Agile Methodologies and testing (e.g., JIRA, TestLink, TestRail, etc.).Strong knowledge of industry regulations and standards and how to apply them in a SaaS environment. This includes but is not limited to: Life Science Regulations (e.g., GxPs), GAMP, IEEE, Verification and Validation (V&V), Financial, FedRAMP, PCI, Privacy-GDPR, ISO 9001/27001/27701, NIST, HIPAA, etc. is desired.Minimum 3 years’ experience of Business / Functional and/or IT experience specific to Software Quality or Computer System Validation.Working knowledge of external risk management and control frameworks (e.g., COBIT, ISO 27001, FedRAMP, CSA, SIG, etc.).Working knowledge of SaaS solutions and deployments from a Software Quality, V&V and/or Computer System Validation (GxP) perspective. Proven project management and organizational skills, specifically managing multiple, concurrent projects.Strong interpersonal, written, and oral communication skills.Highly self-motivated and directed professional, with keen attention to detail.Excellent analytical, problem-solving, and decision-making abilities.Able to effectively prioritize tasks in a high-pressure environment.Strong customer service and solution-focused orientation.Experience working in a team-oriented, collaborative environment.

Validation Specialists must have the ability to:

Elicit, from JIRA and other sources, Critical To Customer (CTC) requirements and document in detailed Software Requirements Specifications (SRSs).Produce and execute Software Test Scripts (STSs) to verify the CTC Requirements.Produce professional-looking, customer-facing and audit-ready, SRSs, STSs and STS Runs, which follow the principles of Good Documentation Practice.Perform peer reviews of SRSs, STSs and STS Runs produced by other IV&V Specialists.Propose and produce internal Knowledge Articles to improve IV&V Team efficiency.Work under pressure in order to deliver on Patch and Release IV&V timelines. Note: Out of hours and weekend work are sometimes necessary.Collaborate with and obtain support from Product Management and Engineering, as appropriate, in order to deliver IV&V evidence.Contribute, proactively, to the “Daily IV&V Stand Up Meetings” with status updates and other input.

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