Simplify

Compliance and Risk Management Specialist

Simplify

full-time

Posted on:

Origin:  • 🇧🇷 Brazil

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Job Level

Mid-LevelSenior

About the role

  • Responsible for the compliance aspects of computerized systems and supporting infrastructure to ensure compliance with company policies, procedures, and regulatory expectations
  • Support the organization’s compliance with the Sarbanes-Oxley Act by evaluating and documenting IT General Controls (ITGC) and related processes
  • Manage change management to ensure compliance and ensure SOX ITGC Controls are identified and addressed for deployments/updates
  • Perform risk assessments and identify key ITGCs related to access management, change management, and IT operations
  • Assist in the design, implementation, and documentation of IT controls
  • Collaborate with control owners to remediate deficiencies and improve control effectiveness
  • Support internal and external audit teams during SOX audits
  • Monitor changes in IT systems and processes that may impact SOX compliance
  • Provide training and guidance on SOX compliance requirements
  • Review processes and supporting documentary evidence to verify compliance activities related to computerized systems are in place and effective
  • Work closely with IT, Internal Audit, and external auditors; conduct role independently with integrity, fairness, and objectivity to protect products and patients

Requirements

  • Bachelor's degree (Preferably Information Systems, Computer Science, Accounting or equivalent)
  • Preferable Professional certifications such as CSOPTM or equivalent
  • Fluent English Speaker
  • Hands-on experience and understanding of systems supporting pharmaceutical companies
  • At least 3 years of experience IT audit, SOX 404 compliance, or IT risk management
  • Familiarity with frameworks such as COBIT, NIST, or ISO 27001
  • Strong understanding of ITGCs and their role in financial reporting
  • Good understanding of the current pharmaceutical industry and applicable regulations (FDA/EU/ICH), with emphasis in 21 CFR Part 11, 210, 211 and 820 and local regulatory expectations
  • Must demonstrate working knowledge of the principles, theories and concepts of computerized system validation / compliance
  • Familiarity or practical experience in the implementation of systems in a pharmaceutical company
  • Limited supervision required in day-to-day activities
  • Excellent analytical, communication, and documentation skills
  • Experience supporting regulatory inspections (preferred)
  • Business engagement skills and ability to collaborate with both technical and non-technical roles
  • Multi-lingual capabilities preferred
  • Project management skills and ability to respond to changing priorities