Ethics & Compliance Specialist/Sr. Specialist

Ethics & Compliance Specialist / Sr. Specialist – Hybrid, Permanent – Pay range $75,000–$135,000 – Location: Fort Lee, New Jersey (Hybrid). Kedrion Biopharma Inc. is an international company that collects and fractionates blood plasma to produce and distribute plasma‑derived therapeutic products for use in treating and preventing serious diseases, disorders and conditions such as Hemophilia, Primary Immune System Deficiencies and Rh‑Sensitization. Job Summary Shape ethical business practices on a global scale. Join Kedrion as a key driver of healthcare compliance and integrity. In this role, you will support and enhance Kedrion’s Global Ethics & Compliance (E&C) System, ensuring the organization meets evolving regulatory obligations while promoting a culture of accountability and transparency. Partnering closely with the Global Compliance Officer and cross‑functional teams, you will help design and implement scalable compliance solutions across global and local markets, including the U.S., with a strong focus on supporting commercial operations. What you’ll do Implement and manage Global Ethics & Compliance initiatives across assigned business lines, functions, and markets, including the U.S. Complete, maintain, and update periodic compliance risk assessments to identify and mitigate emerging risks. Monitor changes in applicable laws, regulations, industry guidance, and best practices that impact the Ethics & Compliance System. Draft, implement, and maintain compliance‑related policies and procedures, including version control, change tracking, and effective rollouts. Develop and deliver compliance training programs and awareness communications for employees and stakeholders. Design and integrate compliance controls into company processes to ensure effective risk management. Present Ethics & Compliance topics and initiatives to internal and external stakeholders as required. Conduct and facilitate auditing and monitoring activities to assess program effectiveness. Manage and support U.S. and global transparency reporting. Manage and support third‑party due diligence activities, including review and approval processes. Contribute to the Global Speak Up Program and support Ethics & Compliance–related investigations. Prepare and deliver periodic reports to company management on monitoring outcomes and compliance initiatives. Support the Global Compliance Officer and Global Ethics & Compliance team in identifying and implementing improvements to the E&C System, with particular focus on the Commercial organization. Participate in performance improvement projects, including the definition and measurement of compliance metrics. Partner cross‑functionally with Legal, Finance, IT, HR, Internal Audit, Quality, and Commercial teams to ensure the Ethics & Compliance System is well designed, effectively implemented, and aligned to business needs. Provide independent compliance advice to help manage and mitigate organizational risk. Qualifications Bachelor’s degree required. 3–5 years of relevant healthcare compliance experience within pharmaceutical, biotechnology, or medical device organizations. Solid understanding of the elements of an effective compliance program, including guidance issued by the U.S. Department of Justice and Office of Inspector General. Experience with healthcare compliance regulations and interactions with healthcare stakeholders such as healthcare professionals, organizations, patient organizations, and payors. Knowledge of anti‑bribery and anti‑corruption legislation, including the Foreign Corrupt Practices Act and similar global regulations. Experience compiling and working with compliance data and analytics. Intermediate to advanced proficiency with Microsoft Office applications, including Excel, Word, Outlook, and PowerPoint. Fluency in English; additional language skills are beneficial. Ability and willingness to travel up to 25% as needed. Compliance certification (e.g., CCEP, CCEP‑I) preferred. Employment Eligibility Employment eligibility verification will be required at the time of hire. This position does not offer visa sponsorship now or in the future. Kedrion Biopharma Inc. is committed to providing equal employment opportunities to all employees and applicants. We prohibit discrimination and harassment based on race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. This policy applies to all employment terms, including recruitment, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training. Benefits Medical, vision and dental insurance Life and AD&D insurance Paid holidays PTO accrual and much more! Please let us know if you would like further details regarding the benefits that we offer to our qualifying employees; we would be glad to provide you with our full benefits guide, as well as answering any questions you may have. If you require assistance with your employment application or need reasonable accommodations to perform job duties, please contact our Talent Acquisition team at View email address on click.appcast.io. #J-18808-Ljbffr Kedrion Biopharma GmbH