IT Risk Regulatory Compliance Specialist

6 days ago

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

CareDx, Inc. is a leading precision medicine solutions company focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers.

CareDx offers products, testing services, and digital healthcare solutions along the pre- and post-transplant patient journey, and is the leading provider of genomics-based information for transplant patients.

The company is seeking an accomplished and dynamic Sr Manager, SOX and IT Compliance, with a strong background in SOX, FDA, EUMDR, CLIA, CAP, GMP, ISO, and IT Systems Change Management, Cross-functional Collaboration, and Project Management.

This individual will be part of the IT team that oversees internal controls over all SOX/FDA/EUMDR/CLIA/CAP/GMP/ISO in scope systems, IT policies, procedures, change, and project management for the company.

The Sr Manager, SOX and IT Compliance, will coordinate SOX-ITGC and other IT regulatory compliance-related activities with the systems owners, cross-functional control owners, internal auditors, external auditors, and outside consultants using a consultative approach.

This role 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.

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 standards and drive remediation efforts for any identified deficiencies.
  • Drive and facilitate ongoing IT compliance training programs for IT process and control owners.
  • Maintain and enhance SOX controls documentation to reflect the current environment and 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 maintaining 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.
  • Ascertain the appropriateness of the Company's protection and safeguarding of assets and recommend areas for improvements.
  • Participate in IT and Cybersecurity Governance Council to help facilitate meetings and reviews proposals timely.

Requirements:

  • Bachelor's degree in Business, Computer Science, Information Systems.
  • Recent hands-on SOX/FDA/EUMDR/CLIA/CAP/GMP/ISO experience, including successful remediation of compliance deficiencies and material weaknesses with similar size companies.
  • 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.
  • Strong planning, project management, and analytical skills.
  • Proficient in Microsoft Office suite applications.
  • Strong process reengineering, root cause analysis, critical thinking, and creative problem-solving.
  • NetSuite, inventory management, LIMS, and related software proficiency preferred.
  • IT ServiceDesk and SLA management using tools like ServiceNow.
  • IT systems, operations, and resource management.

About CareDx:

CareDx is a company that is making a difference in the lives of transplant patients today and has a promising pipeline for the future. We believe in taking great care of our people, so they take even greater care of our patients.

We offer a range of benefits, including health and welfare benefits, a gym reimbursement program, an Employee Stock Purchase Plan, pre-tax commuter benefits, and a Living Donor Employee Recovery Policy that allows up to 30 days of paid leave annually to a full-time employee who makes the selfless act of donating an organ or bone marrow.

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