CSV Auditor, Internal & Supplier Audits (CONTRACTOR) - Oracle Health Sciences
Posted on: November 11, 2019
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.
- *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
- 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
- Work with management on the Internal and Supplier audit
- 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
- Experience in conducting Supplier and Internal audits of
computer systems and/or software suppliers. Strong experience with
- 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
- 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
*Business OperationsOrganization: *OracleTitle: CSV Auditor,
Internal & Supplier Audits (CONTRACTOR) - Oracle Health
SciencesLocation: MA,Mass-BurlingtonRequisition ID: 19001EH8Other
Locations: United States
Keywords: Oracle, Providence , CSV Auditor, Internal & Supplier Audits (CONTRACTOR) - Oracle Health Sciences, Accounting, Auditing , Providence, Rhode Island
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