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Oracle Principal Compliance Specialist in Reno, Nevada

Assists and supports the organization in complying with, as well as the ongoing preparation, testing and monitoring of conformance to, the requirements of government regulations and/or regulatory agencies.

Performs evaluation of internal operations, controls, communications, risk assessments and maintenance of documentation as related to regulatory compliance and recommends appropriate changes. Conducts and facilitates internal and external audits to identify, evaluate, disclose and appropriately remedy risks and deficiencies. Coordinates the preparation of and may prepare document packages for regulatory submissions from all areas of company as well as for internal and external audits and inspections. May serve as point of contact for interactions with regulatory agencies for defined matters. Support the creation of a comprehensive risk management and regulatory oversight program, including specifications for product and service design aligned with Oracle Software Security Assurance and Security Architecture. Review specifications. Develop training for GBU development, cloud services, services and operations teams on industry regulatory specifications applicable to their products and services. Execute risk assessments and evaluate risks to the business and develop risk mitigation strategies. Work with members of GBU development, cloud services, services and operations teams to incorporate applicable industry regulatory standards, Oracle security policies and customer-contractual obligations into GBU processes and standards. Coordinate industry and regulatory certifications, including managing certification vendors (e.g., PCI, HIPAA,HITECH, ISO, SOC2). Build security documentation and collateral for customers and internal users allowing security to be a differentiator in this GBUs. Build management level metrics and reporting for activities that are owned by the Risk Manager. Execute a vendor security program.

Leading contributor individually and as a team member, providing direction and mentoring to others. Work is non-routine and very complex, involving the application of advanced technical/business skills in area of specialization. . Ability to travel. 8 plus years experience. BA/BS or advanced degree preferred. 5-7 years work in governance and compliance for a large corporation. CISA, CISM, CISSP, CIPP desired. Strong knowledge of IT auditing and controls, preferable with SOX, SSAE 16 - SOC 1 & SOC 2, PCI compliance, NIST, DIACAP, FedRAMP, ISO 27001 & ISO 27002. Experience with 21 CFR Part 11 and HIPAA. Knowledge and understanding of the delivery process for validated systems; specifically Computer System Validation process or CSV. Have an understanding of security standards and risk management. Experience working in Information Technology, Cloud or managed hosting services. Excellent written and verbal communication skills. Ability to adjust and adapt to changing priorities in a dynamic environment. Technical acumen and the ability to understand and interpret technical specifications. Technical knowledge of Oracle Applications and Database and/or infrastructure components. Project Management skills.

The Principal Specialist, Risk Management and Regulatory Compliance will share global responsibility with the R&C team to ensure compliance to relevant government and industry regulations (21 CFR 11, ICH GCP, and Guidance for Industry-Computerized Systems Used in Clinical Trials) for the development of software products and delivery of services. Interface with Senior Management, and all levels of functional management throughout the company to create, implement, improve, and monitor quality practices and procedures in accordance with the Quality Management System.

Responsibilities Include:

  • Participate in the independent regulatory, audit, and quality assurance function for global organization.

  • Main responsibility will be to oversee the quality and compliance of cloud deployment activities, including related Development deliveries and Application Management Services. Being a thought leader and trusted advisor for identifying and instituting best practices for these activities. This will entail driving or facilitating QMS deliverables and customer facing documentation, performing internal audits, consulting and tracking of CAPAs, working with key stakeholders (within Health Sciences and other Oracle business units) and presenting compliance status to Senior Management on regular basis.

  • Assist with annual third party compliance assessments and certifications.

  • Key point of contact for representing the overview of Health Sciences cloud deployment activities in customer audits and supporting inspection requests.

  • To stay abreast of industry and federal regulations as cited above, and provide guidance and expertise to the global organization in the areas of regulatory compliance and quality.

  • BS/BA Degree in scientific discipline or 5 years experience as a QA professional in a regulated pharmaceutical environment, or with a Contract Research Organization (CRO), with formal training or experience in regulatory affairs, and quality systems. RAPS certification a plus.

  • Experience with cloud hosting.

  • Experience in conducting IT/cloud audits highly desirable

  • Must have a working knowledge of relevant industry and government regulations, including: 21 CFR 11, ICH GCP, and Guidance for Industry-Computerized Systems Used in Clinical Trials.

  • Must have experience in the development, and maintenance of quality management system.

  • Must possess effective communication skills, and proven abilities in interfacing with customers.

  • Ability to learn quickly and be a self-starter.

  • Ability to manage multiple projects/priorities.

  • Must be methodical, well organized and detail oriented. Individual must be readily adaptable to a fast-paced, multidisciplinary team-based environment.

Job: *Business Operations

Organization: *Oracle

Title: Principal Compliance Specialist

Location: United States

Requisition ID: 210008KE