Quality Lead, Software and IT Compliance
Anywhere
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:
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.
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.
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Eliassen Group is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status. Eliassen Group’s Affirmative Action Plan (AAP) is available for inspection by any employee or applicant for employment upon request, during normal business hours of Monday through Friday, 8:30am to 5:30pm EST. Interested persons should contact Phaedra Wells at pwells@eliassen.com for assistance. It is unlawful in Massachusetts and Maryland to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Applicants with disabilities that believe they require an accommodation or assistance with a position, please email our HR team at hradmin@eliassen.com. This email inbox is designed exclusively to assist job seekers whose disability prevents them from being able to apply online. Emails sent for other purposes will not receive a response.
Please be advised that a number of fraudulent job postings have been released under the Eliassen Group brand.
Unfortunately, fraudulent job postings can happen. If anyone reaches out to you about an open position connected with Eliassen Group, never provide personal or financial information to anyone who is not clearly associated with Eliassen Group
If anyone seemingly from Eliassen Group has ever requested this personal information in the past or does so in the future, please contactInfoSec@eliassen.com.
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, as indicated above