Quality Lead, Software and IT Compliance

Quality Lead, Software and IT Compliance

Anywhere | Contract | Quality Assurance (QA) | Life Sciences | Remote

Reference ID: JN -032026-106136

Date Posted: 03/24/2026

Shortcut:

Rate: $30.00 to $40.00/hr. w2

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.

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 process. You may receive email and SMS notifications from the Eliassen Virtual Recruiting Team ([email protected], 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.

Please be advised- If anyone reaches out to you about an open position connected with Eliassen Group, please confirm that they have an Eliassen.com email address and never provide personal or financial information to anyone who is not clearly associated with Eliassen Group. If you have any indication of fraudulent activity, please contact [email protected].

About Eliassen Group:

Eliassen Group is a leading strategic consulting company for human-powered solutions. For over 30 years, Eliassen has helped thousands of companies reach further and achieve more with their technology solutions, financial, risk & compliance, and advisory solutions, and clinical solutions. With offices from coast to coast and throughout Europe, Eliassen provides a local community presence, balanced with international reach. Eliassen Group strives to positively impact the lives of their employees, clients, consultants, and the communities in which they operate.

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.

Don’t miss out on our referral program! If we hire a candidate that you refer us to then you can be eligible for a $1,000 referral check!