Job Information
Eliassen Group Quality Lead, Software and IT Compliance in Phoenix, Arizona
Quality Lead, Software and IT Compliance
Anywhere
Type: Contract
Category: Quality Assurance (QA)
Industry: Life Sciences
Workplace Type: Remote
Reference ID: JN -032026-106136
Date Posted: 03/24/2026
Shortcut: http://careers.eliassen.com/doevOf
Description
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Description:
Remote
The organization seeks a Quality Lead to maintain and improve the Quality Management System and ensure compliance with FDA and international regulations across enterprise software initiatives. The role shall author and guide SDLC deliverables, lead validation and risk activities, and provide expert quality guidance to IT and software teams. The position will support complex enterprise systems, drive continuous improvement, and collaborate across functions to meet regulatory and business objectives.
Due to client requirements, applicants must be willing and able to work on a w2 basis. For our w2 consultants, we offer a great benefits package that includes Medical, Dental, and Vision benefits, 401k with company matching, and life insurance.
Rate: $30.00 to $40.00/hr. w2
Responsibilities:
Maintain the Quality Management System and ensure compliance with FDA and international regulations and standards.
Lead projects as the Quality Lead across the software development lifecycle.
Author and guide SDLC documentation, including GxP, Part 11, requirements, validation plans, test scripts, and summary reports.
Provide guidance on clear, testable requirements and related test strategies.
Support and collaborate with software development and IT teams in an FDA-regulated environment.
Perform regulation gap analyses and drive updates to the Quality Management System.
Create system and functional risk assessments and validation deliverables.
Map enterprise systems and create engineering deployment and network diagrams.
Create and approve complex test case scripts and automation scripts, and provide validation support.
Guide data migration planning, scripting, and reporting.
Support IT enterprise systems infrastructure, implementation, deployment, post-implementation improvements, and maintenance.
Communicate quality guidance to small teams, peers, and management.
Drive continuous improvement of quality processes and procedures.
Experience Requirements:
Experience interpreting FDA guidance and translating it into SOPs and process instructions.
Background with Quality Management Systems, enterprise computer systems risk management, and validation activities.
Ability to present to small teams and collaborate across diverse functional groups.
Demonstrated diligence for compliance, technical competence, and sound judgment.
Experience guiding teams during validation activities.
Experience creating workflow and deployment diagrams.
Experience in a Quality capacity on large, multi-layered enterprise systems such as SAP, Cloud PLM, Oracle, or Camstar.
Mastery-level understanding of the Software Development Life Cycle.
Experience working within a regulated environment, with prior team lead or managerial exposure preferred.
Ability to learn technical terminology quickly and communicate effectively with software engineering and IT.
Education Requirements:
Bachelor’s degree in a technical discipline.
5 to 7 years of related work experience.
Recruitment Transparency Notice
Eliassen Group values transparency in our recruitment practices. Please be advised that Eliassen Group utilizes artificial intelligence (AI) tools as part of its initial application screening and hiring process. You may receive email and SMS notifications from the Eliassen Virtual Recruiting Team ( noreply@eliassen.com , 781-808-2924) inviting you to complete a brief voice screening as part of your application process. These tools assist our hiring teams in different ways, including but not limited to, assistance in reviewing application materials to help identify candidates whose qualifications most closely match the requirements of the position. All AI-assisted evaluations and responses are reviewed by human recruiters before any hiring decisions are made. The use of AI in our process is intended to support fairness, efficiency, and consistency, and Eliassen Group takes measures to prevent bias or discrimination in connection with its hiring practices. By proceeding, you acknowledge, agree, and consent to Eliassen Group’s use of these tools, including AI tools, as part of the application and hiring process.
Skills, experience, and other compensable factors will be considered when determining pay rate. The pay range provided in this posting reflects a W2 hourly rate; other employment options may be available that may result in pay outside of the provided range.
W2 employees of Eliassen Group who are regularly scheduled to work 30 or more hours per week are eligible for the following benefits: medical (choice of 3 plans), dental, vision, pre-tax accounts, other voluntary benefits including life and disability insurance, 401(k) with match, and sick time if required by law in the worked-in state/locality.
If anyone reaches out to you about an open position connected with Eliassen Group, please ensure that you are working directly with us by confirming the following:
· When you work with Eliassen Group, all email communication will come from an Eliassen.com address, never Gmail, Yahoo, etc.
· Eliassen Group will never ask you for personal information (home address, bank account, or check routing number) until you have worked with someone clearly associated with Eliassen Group.
If you have any indication of fraudulent activity, please contact fraud@eliassen.com .
About Eliassen Group:
Eliassen Group is a strategic consulting firm that helps organizations reach further and achieve more through our technology, business advisory, and life sciences solutions. For nearly 40 years, we have combined exceptional people, deep domain expertise, and intelligent capabilities to expand our clients’ capacity and accelerate meaningful outcomes. We are driven by a purpose to positively impact the lives of our employees, clients, consultants, and the communities we serve.
Eliassen is committed to building a diverse and inclusive team from a variety of backgrounds, perspectives, and skills. We are an Equal Opportunity and Affirmative Action Employer and all employment decisions are based on merit, performance, and business needs. Eliassen does not discriminate on the basis of race, color, gender identity or expression, sexual preference or orientation, sex (including pregnancy, childbirth, and related medical conditions), marital status, creed, religion, physical or mental disability, genetic information, military or veteran status, age, ancestry, national origin, citizenship status, prohibited criminal record inquiries of applicants and employees, or any other category protected by federal, state, or local laws.
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