Compliance Risk Management Specialist

4 days ago

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

About the Role:

CareDx, Inc. is a leading provider of precision medicine solutions for transplant patients and caregivers. As a Sr Manager, SOX and IT Compliance, you will be responsible for overseeing internal controls over all SOX/FDA/EUMDR/CLIA/CAP/GMP/ISO in scope systems, IT policies, procedures, change, and project management for the company.

This role requires a strong background in SOX, FDA, EUMDR, CLIA, CAP, GMP, ISO, and IT Systems Change Management, Cross-functional Collaboration, and Project Management. The successful candidate will be a subject matter expert working with IT, FP&A, Labs, Cybersecurity, and cross-functional process owners to achieve ongoing design, reviewing, testing, improving, and remediating the IT systems controls for regulatory compliance.

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, 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.
  • 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.
  • Maintain a current knowledge base of audit industry practices and ensure best practices are always considered.

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.
  • Strong understanding of current accounting (GAAP) and auditing (GAAS) principles.
  • Strong planning, project management, and analytical skills.
  • Proficient in Microsoft Office suite applications.

What We Offer:

  • Competitive base salary: $145,000 - $175,000 per annum, depending on experience.
  • Health and welfare benefits including a gym reimbursement program.
  • 401(k) savings plan match.
  • Employee Stock Purchase Plan.
  • Pre-tax commuter benefits.

About CareDx, Inc.:

CareDx, Inc. is an Equal Opportunity Employer and participates in the E-Verify program. With products that are making a difference in the lives of transplant patients today and a promising pipeline for the future, it's an exciting time to be part of the CareDx team.

  • Compliance Risk Manager

    4 days 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,...

  • IT Compliance Specialist

    4 days ago

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

    OverviewCareDx, 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.We are seeking an accomplished and dynamic Sr Manager, SOX and IT Compliance (governance, risk, and compliance) subject matter...

  • Senior Risk Management Leader

    4 days ago

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

    ResponsibilitiesLead 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 such as SOX, CLIA, CAP, FDA, EUMDR, ISO, GxP, etc.Update and...

  • Information Security Professional with Comprehensive Risk Management

    2 weeks ago

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

    As a key member of our team, you will play a critical role in protecting our organization's sensitive data and systems from cyber threats. With a strong background in information security and a passion for staying ahead of emerging threats, you will be responsible for designing and implementing robust security measures to safeguard our cloud and network...

  • Safety and Compliance Professional

    3 days ago

    Brisbane, California, United States Entegee Full time

    Join Entegee, a leader in custom automation projects and controls solutions. As an EHS Manager, you will play a critical role in maintaining a safe working environment for our team members.Salary:$75-$85 per hourAbout the Role:We are seeking an experienced EHS Specialist to manage and implement environmental, health, and safety programs. The ideal candidate...

  • Compliance and Operations Coordinator

    4 days ago

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

    Job DescriptionKey Responsibilities:Leave Management:Coordinate with vendors to administer leave programs, ensuring compliance with company policies and relevant legislation.Serve as the primary point of contact for leave-related inquiries from employees, managers, and HRBPs.Partner with vendors to manage ongoing leave cases and administration activities.HR...

  • Revenue Cycle Management Leader

    2 days ago

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

    Job OverviewCareDx, Inc. is a leading precision medicine solutions company focused on developing clinically differentiated healthcare solutions for transplant patients and caregivers.This role is based in Brisbane, California, and requires the candidate to be on-site at least 3 days per week.The estimated salary for this position is around $140,000 -...

  • International Trade Compliance Specialist

    4 weeks ago

    Brisbane, California, United States Expeditors Full time

    Company Overview: Expeditors is a leading international logistics company that connects customers with global markets. With over 18,000 trained professionals and a presence in six continents, we provide customized solutions to meet the sophisticated needs of international trade.">Job Description: As an Air Export Agent at Expeditors, you will be responsible...

  • Biotechnology Quality Management Leader

    3 weeks ago

    Brisbane, California, United States Vera Therapeutics Full time

    OverviewVera Therapeutics is a late-stage biotechnology company focused on developing treatments for serious immunological diseases. Our mission is to advance treatments that target the source of immunologic diseases in order to change the standard of care for patients.About the RoleWe are seeking a highly experienced Vice President, Quality to lead our...

  • Regulatory Submission Specialist Senior Manager

    2 days ago

    Brisbane, California, United States Vera Therapeutics Full time

    Job SummaryWe are looking for a seasoned Regulatory Submission Specialist Senior Manager to lead the preparation of regulatory submission documents in compliance with global regulatory requirements. As a key member of our Regulatory Operations and Regulatory Affairs teams, you will support cross-functional departments and ensure timely and high-quality...

  • EHS Manager

    4 weeks ago

    Brisbane, California, United States Entegee Full time

    Entegee is seeking an experienced EHS Specialist to manage and implement environmental, health, and safety programs.Key Responsibilities:Provide EHS support to labs, facilities, and manufacturing under the direction of the Facilities DirectorImplement and monitor EHS programs for compliance with company policies and regulatory requirementsManage hazwaste...

  • EHS Program Manager

    2 days ago

    Brisbane, California, United States Entegee Full time

    At Entegee, we are seeking an experienced EHS Specialist to manage and implement environmental, health, and safety programs across our custom automation projects.Job OverviewAs a key member of our team, you will provide critical support to labs, facilities, and manufacturing under the direction of the Facilities Director. Your primary responsibility will be...

  • IT Compliance Manager, Regulatory Affairs Specialist

    4 weeks ago

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

    About CareDx, Inc.CareDx is a pioneering precision medicine solutions company that specializes in the discovery, development, and commercialization of innovative healthcare solutions for transplant patients and caregivers. With a strong focus on clinically differentiated products, testing services, and digital healthcare solutions along the pre- and...

  • Meat Specialist

    4 weeks ago

    Brisbane, California, United States The Chefs' Warehouse Full time

    Job OverviewThe Chefs' Warehouse, a leading food distribution company, is seeking an experienced Meat Specialist to join its team. The successful candidate will be responsible for preparing specialty cuts of meat in a timely and efficient manner to meet customer specifications.This role offers a unique opportunity for individuals who are passionate about...

  • IT Compliance and Governance Specialist

    4 weeks ago

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

    Job OverviewCareDx, 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.The company offers products, testing services, and digital healthcare solutions along the pre- and post-transplant patient...

  • Supply Chain Management Leader

    3 weeks ago

    Brisbane, California, United States Tempest Therapeutics Full time

    Job Title: Supply Chain Management LeaderWe are seeking an experienced Supply Chain Management Leader to join our team at Tempest Therapeutics. This role will play a critical part in ensuring the timely and efficient delivery of clinical supplies for our clinical trial programs.The successful candidate will oversee clinical supply chain activities, from...

  • Payment Processing Specialist

    2 days ago

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

    About the RoleThe Reimbursement Specialist position at CareDx, Inc. involves accurately entering payments and adjustments into our billing system or electronic health records (EHR) based on remittance advice. You will be responsible for ensuring that payments are correctly applied to patient accounts and reconciling any discrepancies between billed amounts...

  • Security System Installation Specialist

    3 weeks ago

    Brisbane, California, United States TEKsystems Full time

    Job SummaryWe are seeking an experienced Security System Installation Specialist to install and repair alarm wiring and equipment.About the RoleInstall, program, and test new alarm and security systemsTroubleshoot and resolve issues with alarms and security systemsIDentify risk to customers and provide effective solutionsPerform routine preventative...

  • Medical Director, Global Safety and Pharmacovigilance

    4 weeks ago

    Brisbane, California, United States Vera Therapeutics Full time

    About Vera TherapeuticsVera Therapeutics is a pioneering biotechnology company dedicated to developing innovative treatments for serious immunological diseases. Our mission is to advance groundbreaking therapies that transform the standard of care for patients.Our Product PipelineAt Vera Therapeutics, we are committed to pushing the boundaries of medical...

  • Program Development Manager

    4 weeks ago

    Brisbane, California, United States Freenome Full time

    Transform Cancer Detection with FreenomeFreenome is a pioneering biotech company dedicated to developing innovative tests for cancer detection using standard blood draws. Our multiomics platform combines tumor and non-tumor signals with machine learning to identify cancer in its earliest, most treatable stages.We are driven by a relentless pursuit to save...