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Senior Manager, SOX and IT Compliance
2 months ago
CareDx, Inc. stands at the forefront of precision medicine, dedicated to the innovation, development, and commercialization of unique healthcare solutions tailored for transplant patients and their caregivers. Our offerings encompass a range of products, testing services, and digital healthcare solutions that guide patients through their pre- and post-transplant journeys, establishing us as the premier provider of genomics-based insights for transplant recipients.
We are seeking a skilled and proactive Senior Manager, SOX and IT Compliance, who is a subject matter expert in governance, risk, and compliance. This role demands a robust background in SOX, FDA, EUMDR, CLIA, CAP, GMP, ISO, and IT Systems Change Management, alongside proven capabilities in cross-functional collaboration and project management. The successful candidate will be integral to the IT team, overseeing internal controls across all relevant systems and ensuring adherence to established IT policies, procedures, and project management standards.
Key Responsibilities:
- Serve as the primary expert in SOX/FDA/EUMDR/CLIA/CAP/GMP/ISO Compliance, collaborating with IT, FP&A, Labs, Cybersecurity, and various process owners to design, review, test, and enhance IT systems controls for regulatory compliance.
- Regularly update and align IT processes, systems, controls, and policies with industry standards, driving remediation efforts for any identified deficiencies.
- Facilitate ongoing IT compliance training programs for IT process and control owners to ensure a well-informed team.
- Maintain and enhance documentation for SOX controls to reflect the current operational environment and ensure compliance.
- Proactively engage in planning, prioritization, and delivery of system enhancements, maintaining comprehensive documentation regarding planning, status, and testing results.
- Conduct risk-based internal audits to assess the adequacy and application of IT controls, identifying weaknesses and deficiencies.
- Manage the external audit process, including direct interaction with independent auditors regarding internal control testing.
- Oversee confidential control reviews and special investigations, coordinating with external agencies as necessary.
- Evaluate the effectiveness of the Company's asset protection measures and recommend improvements.
- Participate in IT and Cybersecurity Governance Council meetings, facilitating discussions and timely reviews of proposals.
- Stay updated on audit industry practices, ensuring that best practices are consistently applied.
- Perform all audit-related duties in accordance with the highest professional standards, adhering to guidelines set by the Institute of Internal Auditors (IIA) and the Institute of Information Systems Audit and Control Association (ISACA).
- Undertake additional responsibilities as assigned.
Qualifications:
- Bachelor's degree in Business, Computer Science, or Information Systems.
- Professional certifications such as CISA, CIA, or similar are highly preferred.
- Demonstrated experience with SOX/FDA/EUMDR/CLIA/CAP/GMP/ISO compliance, including successful remediation of deficiencies.
- Experience in the Life Sciences, Medical Device, or Healthcare sectors is preferred.
- A minimum of 7 years of relevant experience, including Big 4 public accounting and corporate IT experience in a multinational public company.
- Strong knowledge of the Sarbanes-Oxley Act, the 2013 COSO framework, and SEC guidance on internal controls over financial reporting.
- Solid understanding of current accounting (GAAP) and auditing (GAAS) principles.
- Exceptional planning, project management, and analytical skills.
- Proficiency in Microsoft Office applications.
- Strong skills in process reengineering, root cause analysis, critical thinking, and creative problem-solving.
- Familiarity with NetSuite, inventory management, LIMS, and related software is preferred.
- Experience with IT ServiceDesk and SLA management tools such as ServiceNow.
- Critical thinking and problem-solving abilities.
- Knowledge of IT systems, operations, and resource management.
Additional Information:
At CareDx, every individual contributes directly to our mission of enhancing the lives of organ transplant patients globally. We prioritize the well-being of our employees, enabling them to provide exceptional care to our patients.
Our comprehensive Total Rewards package includes:
- 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
- And more
We also offer a Living Donor Employee Recovery Policy, providing up to 30 days of paid leave annually for full-time employees who donate an organ or bone marrow.
With innovative products that are positively impacting the lives of transplant patients and a promising pipeline ahead, it is an exciting time to be part of CareDx.
CareDx, Inc. is an Equal Opportunity Employer and participates in the E-Verify program.
By submitting your application, you acknowledge that you have read our U.S. Personnel Privacy Notice and consent to receive communication from CareDx.
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