IT Compliance - Manager/Director

Eliassen Group

Waltham (MA)

Hybrid

Confidential

Full time

13 days ago
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Benefits offered by this job

Medical insurance
Dental insurance
Vision insurance
401k with company match
Life insurance

Job summary

Eliassen Group is seeking an IT Compliance and Controls Consultant to strengthen governance, documentation, and audit readiness across key systems in a regulated life sciences environment. The role partners with IT, stakeholders, control owners, and auditors to build and improve SOX, GxP, CSV, SDLC, and ITIL controls while balancing access reviews and evidence collection.

The position is hybrid with 3–4 days onsite in Waltham, MA, offering W2 and corp-to-corp options and a benefits package

Qualifications

  • Knowledge of SOX audit requirements and experience with SOX auditors.
  • Knowledge of GxP/CSV audit requirements with 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.

Responsibilities

  • Maintain a CMDB and related master data.
  • Create and maintain policies and control procedures for key controls.
  • Test internal controls, document exceptions, and oversee remediation.
  • Baseline testing for key reports for SOX compliance.
  • Create job aids, user guides, and presentations for control owners.
  • Review SOC 1/SOC 2 reports and elevate remediation with stakeholders.
  • Maintain IT Key Vendor List and review SOC reports as needed.
  • Manage quarterly access reviews and review calendars with stakeholders.
  • Oversee user access provisioning, modification, and termination processes.
  • Ensure logging and review of admin activities on key systems.
  • Oversee system change control procedures and SDLC artifacts.
  • Periodic reviews of system changes and automation of compliance processes.
  • Gather production reports and audit trails for reviews.
  • Support USDM/ProcessX change control activities and process reviews.

Skills

SOX audit requirements
GxP/CSV audit requirements
IT SDLC processes
ITIL processes
SOC 1 & SOC 2 compliance
Change management & control
Audit support & evidence collection
Independent work ability
Communicate IT audit requirements
Influence change without authority
Attention to detail
Simplifying compliance processes
GxP in pharma life sciences

Tools

CMDB
SOC 1 reports
SOC 2 reports
USDM/ProcessX

Job description

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 elevate 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.
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