Manager, SOX and IT Compliance

Caredx - Brisbane, CA

Full-time - Manager

Brisbane, CA

Professional, Scientific, and Technical Services

About the position

The Sr Manager, SOX and IT Compliance at CareDx, Inc. is a leadership role focused on governance, risk, and compliance within the IT department. This position is responsible for overseeing internal controls related to SOX, FDA, EUMDR, CLIA, CAP, GMP, and ISO standards, ensuring compliance across IT systems and processes. The role involves coordinating compliance activities, maintaining documentation, conducting audits, and providing training to ensure adherence to regulatory requirements. The Sr Manager will work collaboratively with various departments to enhance compliance frameworks and drive continuous improvement in IT governance.

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.
• 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.
• Proactively participate and guide the team in planning, prioritization, and delivery of system enhancements.
• Conduct risk-based internal audits to determine soundness, adequacy, and application of IT and controls.
• 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.
• 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 facilitate meetings and review proposals timely.

Requirements

• Bachelor’s degree in Business, Computer Science, or 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.
• Minimum 7+ years of relevant work experience in 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 understanding of current accounting (GAAP) and auditing (GAAS) principles.
• Strong planning, project management, and analytical skills.
• Proficient in Microsoft Office suite applications.

Nice-to-haves

• Life science, Medical Device, and Healthcare industry experience preferred.
• NetSuite, inventory management, LIMS and related software proficiency preferred.
• IT ServiceDesk and SLA management using tools like ServiceNow.

Benefits

• 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
• Living Donor Employee Recovery Policy allowing up to 30 days of paid leave for organ or bone marrow donation