IT Compliance - Manager/Director

Description:
Hybrid 3-4 days onsite in Waltham, MA

Our client is a clinical-stage biotechnology company seeking an IT Compliance and Controls Consultant to strengthen governance, documentation, and audit readiness across key systems. The role will partner with IT, business stakeholders, control owners, vendors, and auditors to build and improve SOX, GxP, CSV, SDLC, and ITIL-related controls. The consultant will balance operational responsibilities such as access reviews and evidence collection with project-based initiatives in a regulated life sciences environment.

We can facilitate w2 and corp-to-corp consultants. 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: $120.00 to $130.00/hr. w2

Responsibilities:

• Maintain a CMDB and related master data.
• Create and maintain policies and control procedures, including key controls for SOX compliance.
• Complete periodic testing of internal controls, document exceptions, and oversee remediation plans.
• Identify and complete baseline testing for key reports for SOX compliance.
• Create job aids, user guides, and instructional presentations for control owners and participants.
• Obtain and review SOC 1 reports for key systems, present summaries to stakeholders, and escalate and remediate as appropriate.
• Create and maintain an IT Key Vendor List and obtain and review SOC 1 and SOC 2 reports as appropriate.
• Initiate and oversee periodic audits of user access to key systems.
• Implement and oversee processes for granting, modifying, and terminating user access.
• Ensure appropriate administrative activity logging and review for key systems.
• Initiate and oversee system change control procedures, including preservation of key SDLC artifacts.
• Initiate and oversee periodic reviews of system changes as appropriate.
• Assist in operationalizing and automating compliance processes.
• Manage quarterly access review processes and coordinate review calendars with stakeholders.
• Gather system access and production support reports and distribute for review and approval.
• Track completion of reviews and maintain supporting documentation and audit trails.
• Support USDM / ProcessX change control activities and manage quarterly process reviews.

Experience Requirements:

• Knowledge of SOX audit requirements and experience working with SOX auditors.
• Knowledge of GxP / CSV audit requirements with experience supporting GxP / CSV audits.
• Knowledge of IT SDLC processes and documentation governance.
• Knowledge of ITIL processes.
• Experience with SOC 1 and SOC 2 compliance.
• Experience with change management and change control processes.
• Audit support and evidence collection expertise.
• Ability to work independently and proactively in environments with immature controls.
• Ability to communicate IT audit requirements to both IT and business stakeholders.
• Ability to influence change without direct managerial authority.
• Strong organizational skills and attention to detail.
• Experience simplifying complex compliance processes and driving stakeholder participation.
• Nice to have: GxP experience in pharmaceutical or life sciences environments.

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 (, ) 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.
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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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