Cornerstone onDemand Principal Consultant, Quality and Risk Management (Remote - United States) in Kansas City, Missouri
Cornerstone recognizes 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, financial, insurance, healthcare, federal government, airlines, chemical, and energy and utilities. The Principal Consultant, Quality and Risk Management (QRM) is the foundation to our ability to ensure this critical function is carried out.
The Principal Consultant reports to the Head of Quality, within the QRM organization. The QRM team owns the overarching Quality Management System at Cornerstone.
This role acts as the representative on all aspects of quality and compliance in regard to the Cornerstone SaaS offering. They are a consultant for both our clients and the CSOD internal business units to ensure all parties are well versed on regulatory requirements and how they should be met from a product, process and validation perspective. In addition, the Principal Consultant will assist the sales cycle, such as; developing statements of work, presenting the Cornerstone Quality and Risk management processes, representing how we meet regulated industry expectations and delivering quality and validation services on behalf of CSOD.
In this role you will...
Support the execution and performance of the company's QMS activities. This includes maintaining and integrating the QMS into all Cornerstone functional areas and representing it to prospects and clients.
Provide clear guidance for this area and the company overall by ensuring clear policies, procedures, instructions, forms, & targets are provided.
Coordinate targets and strategies with other functional areas so that objectives are met.
Contribute to the creation and implementation of best practice capacity planning vision, strategy, policies, processes, and procedures.
Contribute to new business initiatives and projects and review and communicate the impact on Quality Management Systems (QMS)
Be the resident regulatory expert to provide quality consulting and oversight to all functional areas
Work directly with the Software Quality Assurance, Technology and Product teams to provide oversight and guidance as it relates to quality processes and industry expectations.
Review and, if necessary, update the QMS periodically, as appropriate.
Ensure the Quality and Risk Management group provides oversight and guidance regarding audits and overall risk management.
Conduct quarterly release validation (Life Sciences), including GxP Impact Assessments; Patches and Hotfixes.
Work closely with clients during the presales process to help position CSOD from a Regulatory compliance aspect and scoping of quality and validation services. Educate sales and implementation teams on regulatory compliance areas (e.g. life sciences, financial and insurance, healthcare, federal government, and energy and utilities, etc.).
Scope Engagements such as body of work and services, draft SOW language and estimate cost/time for compliance efforts
Manage and ensure that Compliance-related changes are on the roadmap for regulated clients, including new features / functions. Develop new services for Regulatory Compliance and update/refine existing services.
Where needed, deliver all services related to Quality and Risk Management service offerings to Cornerstone clients. This includes; IT Controls/Validation Audit, CSOD Validation Engagement Consulting, Validation Workshops, and Validation Maintenance.
Provide applicable regulatory, industry best practice and client expectation awareness for quality and validation standards and principles.
Be recognized as a thought leader in the industry specifically to regulated clients (e.g., life sciences, financial and insurance, healthcare, federal government, and energy and utilities, etc.).
Bachelors or master’s degree in Information Systems, Computer Science or related discipline, or equivalent work experience
Strong knowledge of industry regulations and standards and how to apply them in a SaaS environment. Including but not limited to: Life Science Regulations (e.g. GxPs), GAMP, Financial, FedRAMP, PCI, Privacy-GDPR, ISO 9001/27001/27701, NIST, HIPAA, etc. is desired
7+ years’ experience of Business/Functional and/or IT experience specific to Quality and 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 Quality and Computer System Validation perspective
Ability to interact and manage client-specific workshops remotely and at client sites
Proven project management and organizational skills, specifically managing multiple, concurrent projects
Strong written and verbal communication abilities
Highly motivated and directed professional, with keen attention to detail
Excellent problem-solving and decision-making abilities
Able to prioritize tasks in a high-pressure environment
Strong customer service and solution-focused orientation
Experience working in a team-oriented environment
Willing and able to travel approximately 35% to off-site locations and client locations
Equal Employment Opportunity has been, and will continue to be, a fundamental commitment at Cornerstone OnDemand. All qualified applicants are given consideration regardless of race, color, gender, age, sexual orientation, national origin, marital status, citizenship status, disability, veteran status, or any other protected class as provided in applicable Federal, State, or Local fair employment laws. If you have a disability or special need that requires accommodation, please contact us at email@example.com