Compliance Program Lead, Risk Management and Regulatory Compliance Principal Specialist

The Compliance Program Lead, Risk Management and Regulatory Compliance Principal Specialist will share global responsibility with the R&C 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 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:
1. Medical, dental, and vision insurance, including expert medical opinion
2. Short term disability and long term disability
3. Life insurance and AD&D
4. Supplemental life insurance (Employee/Spouse/Child)
5. Health care and dependent care Flexible Spending Accounts
6. Pre-tax commuter and parking benefits
7. 401(k) Savings and Investment Plan with company match
8. 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.
9. 11 paid holidays
10. 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 o