Senior Validation Engineer, QRM Position Available In New York, New York

Job Order Number:

DG0213850

Job Title:

Senior Validation Engineer, QRM

Company:

Cornerstone on

Demand Location:

New York, NY

Salary:

Education:

Information Not Provided

Experience:

Information Not Provided

Hours:

Duration:

Full Time, Regular

Shift:

Description:

 Cornerstone provides SaaS-based solutions tailored for customers in regulated industries such as Life Sciences, Banking, Manufacturing, Healthcare, and Government and ensures that our software systems meet both functional specifications and intended use for our regulated customers. The Senior Validation Engineer plays a vital role in this process through oversight of the Independent Verification and Validation (IV&V) efforts. The output is utilized and leveraged by regulated customers that purchase Cornerstone’s IV&V Maintenance Service. This position reports to the AVP, Quality and Risk Management (QRM) within the Cybersecurity Engineering & Assurance organization and is a strategic role within the company.•About the Quality and Risk Management (QRM) Team•The QRM team is responsible for establishing and maintaining the overarching Quality Management System (QMS) at Cornerstone. This system governs compliance across the company and provides regulatory expertise, operational support, and strategic consulting.

Key areas of responsibility include:

+ 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 customers).•Role Responsibilities•As the Senior Validation Engineer, you will oversee the IV&V (Independent Verification & Validation) lifecycle for Cornerstone’s validated SaaS Learning Management System (LMS), which is deployed to customers in heavily regulated industries. You are a seasoned strategic leader and will ensure our software meets all validation requirements through structured methodologies, risk-based approaches, and regulatory best practices in a fast-paced environment.•In this role you will…•+ Strategically manage validation activities for software releases and patches (three major Releases annually)+ Collaborate cross-functionally with Product, Engineering, and Software Quality Assurance teams to develop, support, and maintain a software validation package that demonstrates verification and validation activities for the Cornerstone Solution and is leveraged by customers in regulated industries+ Lead a team of validation engineers and drive timely customer-facing documentation and deliverables+ Develop and review essential validation deliverables such as Risk Assessments, Test Scripts, Functional Requirements and Traceability Matrices, and Summary Reports+ Apply risk-based validation techniques in accordance with GxP, GAMP 5, and global compliance frameworks+ Act as the point of contact for customer inquiries related to IV&V activities+ Monitor regulatory developments and integrate changes into internal procedures+ Work closely with the global Cybersecurity and Assurance Team to implement security standards across the organization+ Support audits, CAPA responses, and maintain documentation for the system lifecycle+ Represent Cornerstone in industry events, forums, and special interest groups to establish thought leadership and stay abreast of industry best practices+ Effectively communicate program status, risks, and outcomes to

AVP, QRM.

•You’ve got what it takes if you have…•+ Bachelor’s or Master’s degree in Information Systems, Computer Science, or a related technical field (preferred)+ In-depth knowledge of regulatory frameworks such as GxPs (e.g., 21 CFR Part 11, 58, 210, 211, 820, EU Annex 11, etc.), GAMP 5, ALCOA++, ICH, GDPR, Fed

RAMP, HIPAA, PCI, ISO

9001/27001/27701, and NIST+ A minimum of 7 years’ experience leading validation projects in life sciences, healthcare, or financial services+ Hand-on experience validating (CSV) regulated SaaS systems, including Learning Management Systems or platforms used in the life sciences industry. The ideal candidate will have experience in a Technology company that supplies systems to customers wh