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Operational Audit Lead

Job in Northbrook, Cook County, Illinois, 60065, USA
Listing for: Astellas Pharma
Full Time position
Listed on 2025-12-01
Job specializations:
  • Management
Job Description & How to Apply Below

Join to apply for the Operational Audit Lead role at Astellas Pharma
. Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!

Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people worldwide. This position is based in Northbrook, Illinois.

Hybrid work from certain states may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines. Candidates interested in hybrid work are encouraged to apply.

Purpose

This role is responsible for conducting risk assessment activities and developing appropriate audit programs for complex and varied global and regional topics (operational, financial, compliance, and/or IT). It manages internal audit projects, including budgeting, timeline monitoring, fieldwork testing, and directing audit members. The role prepares audit reports, follows up on identified issues, and supports communication with Astellas Top Management and the Audit and Supervisory Committee.

Essential

Job Responsibilities
  • Annual Risk Assessment and Continual Risk Monitoring
    • Assist in identifying and evaluating the organization’s risks and provide input for the Annual Audit Plan.
    • Participate in risk interviews with key stakeholders, summarize results, and identify key themes and trends to propose annual audit projects.
    • Conduct independent research to evaluate pharmaceutical industry risks and monitor regulatory changes and emerging risks.
    • Maintain the global risk register and support long‑term audit planning.
  • Internal Audit Project Management
    • Lead complex global and regional projects from planning to reporting.
    • Conduct stakeholder interviews and review internal documents to deliver Audit Planning Summary and Memorandum.
    • Prepare audit budgets, timelines, and resource allocations.
    • Develop draft audit programs and fieldwork plans to assess control effectiveness.
    • Manage fieldwork processes, document work papers, and identify audit observations.
    • Communicate results via written reports and oral presentations to stakeholders and senior management.
    • Build and maintain productive relationships with clients, staff, and management.
    • Provide advice and counsel to management to improve internal processes and controls.
  • Co‑source Oversight
    • Provide day‑to‑day oversight of third‑party co‑source members supporting audit projects.
    • Ensure roles and responsibilities are well understood across the team.
    • Oversee timely delivery of work papers and deliverables that meet IIA Standards.
    • Manage budgets of individual projects and flag potential overruns.
  • Other Responsibilities
    • Coordinate and partner with other governance functions to ensure risk coverage and avoid duplication.
    • Lead or perform other internal initiatives to achieve the vision of Internal Audit.
Qualifications Required
  • Bachelor of Science or Bachelor of Arts degree.
  • Relevant professional auditing and accounting certifications preferred (e.g., Chartered Accountant, Certified Internal Auditor, CPA, etc.).
  • Minimum 7 years of experience in internal auditing, accounting, or compliance, including management and supervisory experience; 3 of the 6 years can be project management, team management, and related organizational skills.
  • Excellent verbal and written communication skills in English.
  • Strong data analysis and organizational skills.
  • Proven experience managing and leading internal audits in line with professional standards, policies, and procedures.
Qualifications Preferred
  • Previous internal audit or public accounting experience in a nationally recognized firm (e.g., Big
    4) and life science industry experience preferred.
  • Subject matter expertise in medical research and development related activities (e.g., healthcare compliance, operations,…
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