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Years of Experience
Date Last Verified
ProfileCompliance Leader RESPONSIBILITIES: Responsible for leading the Compliance Program for non-health regulatory matters for Cepheid’s molecular diagnostics business. Collaborate with compliance and business colleagues to develop, implement, and maintain the Compliance Program for Cepheid, to include implementing written policies, procedures, and standards of conduct, leading effective training programs, conducting internal monitoring and auditing, and directing investigations to respond promptly to detected offenses and undertake corrective actions. Will partner with the Cepheid leadership team to ensure compliance with industry, regulatory, and Corporation requirements. Will also proactively identify compliance-related gaps or issues and advise the leadership team on how to mitigate potential risks. Responsible for the platform’s Compliance Program planning and development functions, ensuring there is a plan designed to meet all Compliance Program requirements, in line with appropriate regulatory requirements. Promote (a) use of the Compliance Hotline, (b) heightened awareness of Standards of Conduct, and (c) understanding of new and existing compliance issues and related policies and procedures. Monitor and report results of the compliance/ethics efforts within the Diagnostic platform and provide guidance for senior leadership on matters relating to compliance. Monitor the performance of the Compliance Program and related activities on a continuing basis, taking appropriate steps to improve effectiveness. Act as a strategic business partner for senior leadership on matters of major importance to the company and provide information related to all aspects of the company’s compliance, including reporting ongoing compliance issues and intentional acts of non-compliance, fraud, waste and abuse. Identify potential areas of compliance vulnerability and risk; develop and implement corrective action plans for resolution of problematic issues, and provide general guidance on how to avoid or deal with similar situations in the future. Collaborate closely with colleagues in Legal, Internal Audit, HR, Finance and other core functions in order to direct compliance issues through the appropriate channels for investigation and resolution as well as work towards future improvements as the Compliance Program evolves. Monitor, and coordinate with Chief Regulatory Officer compliance activities of other departments to remain abreast of the status of all compliance activities and to identify trends. Partner with the appropriate business areas to deliver supplemental compliance training that further amplifies the corporate program, engages employees, and addresses specific needs within Cepheid or the Diagnostics platform.
Qualification and Experience
Qualifications: Bachelor of Science or Bachelor of Arts degree required. JD Degree or Masters of Business Administration are preferred. 10+ years’ experience in compliance role. Additional 5+ years’ experience of managing people is preferred. Compliance certifications/credentials preferred. In-depth knowledge of applicable regulatory and compliance requirements, including the U.S. Foreign Corrupt Practices Act, the False Claims Act and the Anti-Kickback Act, with an understanding of how these requirements apply to the organization’s daily operations. In-depth knowledge and understanding of compliance risk management practices and methodologies, including risk assessment, monitoring/surveillance, and testing activities. Strong project management skills, to include managing and prioritizing multiple concurrent projects, mapping budget and resource curves, and reporting progress and risks to colleagues and senior management. Strong business and financial acumen, with demonstrated understanding of core business processes. For example, prior contribution to/participation in strategy planning and product development processes. In-depth experience in conducting global investigations and managing the entire investigations process, including the management and tracking of the investigation lifecycle and the close-out process. Preferred ability to act as a clearinghouse for compliance lessons learned and best practices. Preferred experience in the Life Sciences, Medical Device or Pharmaceutical industry. Preferred experience in developing and maintaining effective lines of communication, including the management of a Compliance Hotline. Preferred experience in the development, initiation, maintenance, and revision of policies and procedures for the general operation of a Compliance Program and its related activities to prevent illegal, unethical, or improper conduct. Preferred experience in monitoring the performance of a Compliance Program and related activities on a continuing basis and taking appropriate steps to improve effectiveness.