Ethics & Compliance Manager

The Ethics & Compliance Manager (“Manager”) contributes to the design, implementation and continuous improvement of Kedrion’s data security plan protecting plasma donor personal data. Additionally, the Manager contributes to the Global Ethics and Compliance System of Kedrion Biopharma (e.g., written guidelines, trainings and awareness initiatives, internal controls and monitoring system, Speak Up and periodic reporting) for the assigned company business lines and/or functions.This is a deeply operational and cross-functional role that will directly support global initiatives and drive the development and execution of scalable solutions that comply with new and evolving obligations. We'd like this person to be in the Raleigh, NC area or near Fort Lee, NJ, preferably.

Under the supervision of the Global Compliance Officer/Security Officer, the Manager will support the development, implementation and management of the donor data security plan and Ethics & Compliance (“E&C”) initiatives at global level and for specific Kedrion affiliates including, but not limited to, the following activities:

General Focus

Design, implement and manage:

• Training and communications initiatives.
• Internal reporting with the integration of compliance controls into business processes.
• Compliance-related policies and procedures keeping an oversight of version control, change tracking and effective roll-outs.
• Presentations on E&C/Security topics/initiatives during meetings with company’s internal and external stakeholders.  
• Periodic risk assessments.
• Auditing and monitoring activities.
• Third party due diligence activities, including review and approval processes.
• Systems and processes for monitoring changes in applicable laws and regulations (including industry guidance and best industry practices) that are relevant to or impact the data security plan or the E&C System in the countries where Kedrion operates.
• Digital tools supporting compliance activities.
• The Kedrion Global Speak Up Program and internal data security and E&C investigations. 

Support the Global Compliance Officer/Security Officer and the Global Ethics & Compliance Team in identifying areas of improvement for the data security plan and the Global Ethics & Compliance System.

Participate in the development of performance improvement projects (e.g. definition and measurement of compliance metrics,…).

Partner with Kedrion Leaders and Company Functions (e.g., Legal, IT, HR, Quality, etc.) to ensure that the data security plan and the E&C System are properly designed and effectively implemented in the different areas of the Kedrion Organization.

Requirements

• Bachelor’s Degree
• 6-8 years relevant compliance and privacy experience, preferably in pharma or biotech
• IAPP Certification (e.g., CIPP/US, CIPM, CIPT) (preferred but not required)
• Experience with Data Security and Information Security compliance programs, best practices and enterprise IT/IS governance
• Knowledge of Foreign Corrupt Practices Act, Anti-Kickback Statute, (e.g., basic understanding of the basic elements of an effective compliance program and guidance issued by the DoJ and OIG) and of other U.S. and international regulations applying to Pharma Companies
• Experience in privacy program management
• Strong skills in analytical thinking, specifically, ability to identify and define problems, collect data, establish facts and develop substantiated conclusions. 
• Strong project management skills with the ability to manage multiple projects requiring cross-functional collaboration 
• Excellent attention to detail and accuracy 
• Ability to work effectively under multiple time deadlines. 
• Ability to identify and resolve problems in a timely manner and analyze information skillfully; ability to assess risk exposure and appropriately escalate 
• Maintain confidentiality in all matters 
• Ability to express facts and ideas clearly and concisely, both orally and in writing. 
• Intermediate to advanced computer skills including Microsoft Office Suite (i.e. Excel, Word, Outlook, PowerPoint). 
• Excellent interpersonal and organizational skills; listens and gets clarification; responds well to questions. 
• Ability to work with independently with under general guidance and supervision 
• Ability to professionally interact with all levels of employees up to Executives, BODs, Attorneys, etc.   
• Willingness and curiosity to learn 
• Fluent English (knowledge of additional languages of countries where Kedrion operates is highly appreciated)