
IT Compliance Manager, Governance and Risk
6 days ago
Job Summary
CareDx is seeking an accomplished IT Compliance Manager to oversee internal controls over all in-scope systems, IT policies, procedures, change, and project management for the company.
Key Responsibilities- Lead as the 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 such as SOX, CLIA, CAP, FDA, EUMDR, ISO, GxP, etc.
- 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.
- Proactively participate and guide the team in planning, prioritization, and delivery of system enhancements using unified methodologies as well as maintains documentation concerning planning, status, testing results, and other reporting needs.
- Conduct risk-based internal audits to determine soundness, adequacy, and application of IT and controls including identifying control weaknesses, exceptions, and deficiencies in operations.
- Manage the year-end external audit, including direct interaction with independent auditors on internal control testing.
- Oversee confidential control reviews, special investigations, and other ad-hoc projects including coordination of any investigations performed by external agencies.
- Bachelor's degree in Business, Computer Science, Information Systems.
- Professional certification such as CISA, CIA, or similar is strongly required.
- 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.
- Minimum 7+ years of relevant work experience (Big 4 public accounting and corporate IT and SOX regulatory experience in a multi-public company).
- Competitive base salary and incentive compensation
- Health and welfare benefits including a gym reimbursement program
- 401(k) savings plan match
- Employee Stock Purchase Plan
- Pre-tax commuter benefits
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