Compliance Risk Manager

3 weeks ago


Brisbane, California, United States CareDx, Inc. Full time

CareDx, Inc. is a leading provider of genomics-based information for transplant patients, and we are seeking an accomplished Sr Manager, SOX and IT Compliance to oversee internal controls over all SOX/FDA/EUMDR/CLIA/CAP/GMP/ISO in scope systems.

This role involves coordinating SOX-ITGC and other IT regulatory compliance related activities with systems owners, cross-functional control owners, internal auditors, external auditors, and outside consultants using a consultative approach. The successful candidate will update and maintain company-wide control standards, perform SOX/audit projects, and provide control-related training to process owners.

The Sr Manager, SOX and IT Compliance will be responsible for maintaining and preparing clear, detailed, and accurate SOX/FDA/EUMDR/CLIA/CAP/GMP/ISO IT documentation, including systems diagrams, control descriptions, risk control matrices, and partnering with business control owners in planning the IT and GITC compliance testing program.

We estimate the annual salary for this position to be around $120,000-$150,000 based on industry standards and requirements.

Key Responsibilities:
  • Lead as the SOX/FDA/EUMDR/CLIA/CAP/GMP/ISO Compliance subject matter expert working with IT, FP&A, Labs, Cybersecurity and cross-functional process owners to help achieve ongoing design, reviewing, testing, improving, and remediating the IT systems controls for regulatory compliance.
  • Update and align IT processes, systems, controls, and policies to industry's standard and drive remediation efforts for any identified deficiencies.
  • Drive and facilitate on-going IT compliance training programs for IT process and control owners.
  • Maintain and enhance SOX controls documentation so they reflect the current environment and would comply with SOX compliance, including testing documentation and systems diagrams.
Requirements:
  • Bachelor's degree in Business, Computer Science, Information Systems.
  • Professional certification such as CISA, CIA, or similar is strongly preferred.
  • Recent hands-on SOX/FDA/EUMDR/CLIA/CAP/GMP/ISO experience including successful remediation of compliance deficiencies and material weaknesses with similar size companies required.
  • Life science, Medical Device, and Healthcare industry experience preferred.
  • Minimum 7+ years of relevant work experience (Big 4 public accounting and corporate IT and SOX regulatory experience in a multi-national public company).
  • Strong understanding of the Sarbanes-Oxley Act, the 2013 COSO framework, and SEC guidance for management's assessment of internal controls over financial reporting.

We offer a competitive Total Rewards package, including a base salary of $120,000-$150,000, health and welfare benefits, 401(k) savings plan match, Employee Stock Purchase Plan, pre-tax commuter benefits, and more.



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