Job Description

The Compliance Program Lead, Risk Management and Regulatory Compliance Principal Specialist will share global responsibility with the RC team to ensure compliance to relevant government and industry regulations/standards/guidance for the development of software products and delivery of services intended for the Life Sciences clinical trial and safety domains. This role will interact with Senior Management, and all levels of functional management throughout the company to develop and monitor quality practices and procedures in accordance with the Quality Management System.

Career Level - IC4

Responsibilities

Responsibilities Include:

Participate in regulatory, audit, and quality assurance function for the Health Compliance Organization.

Assess the compliance of Oracle Life Sciences products and cloud services including related development, support and application management activities.

Being a thought leader and trusted advisor for identifying and instituting best practices. This will entail the performance of internal audits, consulting and the tracking of CAPAs, working with key stakeholders (within Life Sciences and other Oracle business units), collating and reporting compliance/quality metrics to Senior Management on a regular basis.

Assist with annual third-party compliance assessments and certifications.

Act as a key point of contact for representing the overview of Health Sciences cloud deployment activities in customer audits and supporting inspection requests.

Provide guidance and expertise to the Health Compliance 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/medical device environment, or with a Contract Research Organization (CRO), with formal training or experience in quality systems and audit. RAPS, RQA, security certification a plus.

Experience with cloud hosting.

Experience in conducting IT/cloud or clinical compliance audits

Must have a working knowledge of relevant industry and government regulations/guidance applicable to the life sciences domain including United States 21 CFR 11 rule and the ICH E6 (GCP) guideline.

Familiarity and practical experience of validation in a “GxP” domain and the application of ISO/IEC 9001 and ISO/IEC 27001.

Must have experience in the development, and maintenance of quality management systems`.

Must possess effective communication skills, and proven abilities in interfacing with customers and/or regulators.

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.

Disclaimer:

Certain US customer or client-facing roles may be required to comply with applicable requirements, such as immunization and occupational health mandates.

Range and benefit information provided in this posting are specific to the stated locations only

US: Hiring Range in USD from: $87,000 to $178,100 per annum. May be eligible for bonus and equity.

Oracle maintains broad salary ranges for its roles in order to account for variations in knowledge, skills, experience, market conditions and locations, as well as reflect Oracle’s differing products, industries and lines of business.

Candidates are typically placed into the range based on the preceding factors as well as internal peer equity.

Oracle US offers a comprehensive benefits package which includes the following:

Medical, dental, and vision insurance, including expert medical opinion

Short term disability and long term disability

Life insurance and ADD

Supplemental life insurance (Employee/Spouse/Child)

Health care and dependent care Flexible Spending Accounts

Pre-tax commuter and parking benefits

401(k) Savings and Investment Plan with company match

Paid time off: Flexible Vacation is provided to all eligible employees assigned to a salaried (non-overtime eligible) position. Accrued Vacation is provided to all other employees eligible for vacation benefits. For employees working at least 35 hours per week, the vacation accrual rate is 13 days annually for the first three years of employment and 18 days annually for subsequent years of employment. Vacation accrual is prorated for employees working between 20 and 34 hours per week. Employees working fewer than 20 hours per week are not eligible for vacation.

11 paid holidays

Paid sick leave: 72 hours of paid sick leave upon date of hire. Refreshes each calendar year. Unused balance will carry over each year up to a maximum cap of 112 hours.

Paid parental leave

Adoption assistance

Employee Stock Purchase Plan

Financial planning and group legal

Voluntary benefits including auto, homeowner and pet insurance

The role will generally accept applications for at least three calendar days from the posting date or as long as the job remains posted.

About Us

As a world leader in cloud solutions, Oracle uses tomorrow’s technology to tackle today’s problems. True innovation starts with diverse perspectives and various abilities and backgrounds.

When everyone’s voice is heard, we’re inspired to go beyond what’s been done before. It’s why we’re committed to expanding our inclusive workforce that promotes diverse insights and perspectives.

We’ve partnered with industry-leaders in almost every sector—and continue to thrive after 40+ years of change by operating with integrity.

Oracle careers open the door to global opportunities where work-life balance flourishes. We offer a highly competitive suite of employee benefits designed on the principles of parity and consistency. We put our people first with flexible medical, life insurance and retirement options. We also encourage employees to give back to their communities through our volunteer programs.

We’re committed to including people with disabilities at all stages of the employment process. If you require accessibility assistance or accommodation for a disability at any point, let us know by calling +1 888 404 2494, option one.

Disclaimer:

Oracle is an 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 and protected veterans’ status, or any other characteristic protected by law. Oracle will consider for employment qualified applicants with arrest and conviction records pursuant to applicable law.

* Which includes being a United States Affirmative Action Employer