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Oracle CSV Auditor, Internal & Supplier Audits (CONTRACTOR) - Oracle Health Sciences in Ogden, Utah

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.

Oracle is an Affirmative Action-Equal Employment Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability, protected veterans status, age, or any other characteristic protected by law.

ThisPrincipal Specialist, Risk Management and Regulatory Compliance(CONTRACTOR) *will share global responsibility with the Risk Management & Regulatory Compliance (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 performInternal and Supplier Audits*. Inform Senior Management of any corporate non-compliance incidents or regulatory compliance issues, which may arise internally, with outside customers or with third party contractors.

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Responsibilities Include:

  • Perform Internal Audits on processes and deliverables supporting Oracle Health Sciences.

  • Perform Supplier Audits

  • Generate the Internal and Supplier audit reports and create the applicable CAPAs.

  • Provide input and guidance based on audit observations and from a regulatory and quality perspective to functional areas of the corporation to facilitate decision-making and actions related to product development/release, delivery of services and customer relations.

  • Work with management on the Internal and Supplier audit schedules.

Preferred Qualifications

  • BS/BA degree in scientific discipline or 10 years of 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.CQA highly desirable.

  • Experience in conducting Supplier and Internal audits of computer systems and/or software suppliers. Strong experience with Agile SDLC.

  • 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 be a self-starter; takes initiative, and have the ability to work independently and manage multiple project/priorities.

  • Superior communication skills (interpersonal, verbal, presentation written, email).

  • Must be methodical, well organized and detail oriented.

  • Must be readily adaptable to a fast-paced, multidisciplinary team-based environment.

  • Ability to travel.

Position Location: Strongly prefer candidates near*Burlington, MA. *May consider qualified candidates in other US-locations.

PLEASE NOTE: This is a 6-month contract role; not a full time/employee hire.


Job: *Business Operations

Organization: *Oracle

Title: CSV Auditor, Internal & Supplier Audits (CONTRACTOR) - Oracle Health Sciences

Location: MA,Mass-Burlington

Requisition ID: 19001EH8

Other Locations: United States