Regulatory Enterprise Architect

Description

Job Description:

Leidos Government Health and Safety Solutions Operations is seeking Regulatory Enterprise Architect with experience in the FDA regulatory review processes and agile software development. The candidate will be responsible for analyzing and leading the modernization FDA’s regulatory review processes, which supports the mission of ensuring the safety and efficacy of biological products.  The Architect will translate the needs of regulatory reviewers into technical requirements by analyzing existing business needs, designing new solutions, and overseeing the implementation of process changes/ workflows and improvements.

Primary Responsibilities

• Serve as a technical and business process leader and trusted advisor

• Works closely with customers to understand their business requirements and offer solutions

• Translate business process requirements and processes into technical requirements

• Lead the development, customization and configuration of business process applications

• Design and implement architecture to account for complex integrations

• Evaluate user requirements for digital process automation to determine feasibility and technical requirements

• Support engagement with leaders to ensure high-quality delivery

• Lead and mentor teams focused on short-term and long-term BPM-related software deployments

Basic Qualifications

• Bachelor’s degree (preferably in IT) and more than seven years of experience related to architecting/managing and/or leading teams in BPM software development

• Strong Oracle BPM suite design and implementation experience.

• Experience implementing OpenShift

• Experience implementing no code/low code solutions (e.g., Appian, Pega, Salesforce) to support business transformation

• Experience with FDA regulatory review processes

• Experience with agile software development and DevSecOps

• Ability to obtain a Public Trust Clearance

Pay Range:

#Remote

Covid Guidance

In order to enter Leidos facilities in the U.S. and to attend Leidos events outside our facilities, employees are required to be vaccinated for COVID-19 or maintain proof of a negative COVID-19 test within 96 hours of entry. In addition, we are receiving guidance from certain customers that onsite contractor personnel will need to be fully vaccinated to access customer facilities. If you are not vaccinated, please consider getting your COVID-19 vaccination as soon as possible. If you have any questions, please contact your Talent Acquisition POC. 

About Leidos

Leidos is a Fortune 500® technology, engineering, and science solutions and services leader working to solve the world’s toughest challenges in the defense, intelligence, civil, and health markets. The company’s 43,000 employees support vital missions for government and commercial customers. Headquartered in Reston, Virginia, Leidos reported annual revenues of approximately $13.7 billion for the fiscal year ended December 31, 2021. For more information, visit www.Leidos.com.

Pay and Benefits

Pay and benefits are fundamental to any career decision. That's why we craft compensation packages that reflect the importance of the work we do for our customers. Employment benefits include competitive compensation, Health and Wellness programs, Income Protection, Paid Leave and Retirement. More details are available here.

Securing Your Data

Leidos will never ask you to provide payment-related information at any part of the employment application process. And Leidos will communicate with you only through emails that are sent from a Leidos.com email address. If you receive an email purporting to be from Leidos that asks for payment-related information or any other personal information, please report the email to [email protected].

Commitment to Diversity

All qualified applicants will receive consideration for employment without regard to sex, race, ethnicity, age, national origin, citizenship, religion, physical or mental disability, medical condition, genetic information, pregnancy, family structure, marital status, ancestry, domestic partner status, sexual orientation, gender identity or expression, veteran or military status, or any other basis prohibited by law. Leidos will also consider for employment qualified applicants with criminal histories consistent with relevant laws.