Ethics & Compliance Manager Barga

Ethics & Compliance Manager
Barga
Toscana, Barga

Kedrion Biopharma 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.

Ethics & Compliance Manager Under the supervision of the Global Compliance Officer, designs, implements and manages Ethics & Compliance ("E&C") initiatives at global level and for specific markets in which Kedrion operates including, but not limited to, the following activities: • Completing and updating periodic compliance risks' assessments. • Developing and maintaining 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 E&C System in the countries where Kedrion operates. • Drafting and implementing compliance-related policies and procedures, keeping an oversight of version control, change tracking and effective roll-outs. • Conducting training and executing communications initiatives. • Designing and implementing compliance controls into Company's processes. • Present on E&C topics/initiatives during meetings with company's internal and external stakeholders.

• Conduct and facilitate auditing and monitoring activities. • Conduct and facilitate third party due diligence activities, including review and approval processes. • Implement digital tools supporting compliance activities. • Administer the Kedrion Global Speak Up Program and E&C investigations.

• Periodically report to the Management of the Company on the outcomes of the monitoring activities and other E&C initiatives.

Supports the Global Compliance Officer and the Global Ethics & Compliance Team in identifying areas of improvement for the Global Ethics & Compliance System, with an intent to focus on the Commercial Organization.

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

Partners with Company Functions (, Legal, Finance, IT, HR, Internal Audit, Quality, Commercial, etc. )

to ensure that the E&C System is properly designed and effectively implemented in the different areas of the Kedrion Organization and to provide independent advice to manage compliance risks.

Requirement: • Bachelor's Degree• 6-8 years relevant compliance experience, in pharma, biotech or medical devices• Understanding of the basic elements of an effective compliance program and guidance issued by the DoJ and OIG)• Strong communication and interpersonal skills (, ability to express facts and ideas clearly and concisely, both orally and in writing, listening and getting clarifications, answering questions)• Strong skills in analytical thinking, specifically, ability to identify and define problems, collect data, establish facts and develop substantiated conclusions.

• Excellent attention to detail and accuracy • Ability to manage multiple projects requiring cross-functional collaboration and to work under multiple time deadlines • Problem solving and solutions orientation• Maintain confidentiality in all matters • Intermediate to advanced computer skills including Microsoft Office Suite ( Excel, Word, Outlook, PowerPoint)• Ability to work with independently, 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• Willingness and ability to travel as necessary (not to exceed 25%) • Fluent English and Italian are required (knowledge of additional languages of countries where Kedrion operates is highly appreciated)• Experience with regulations on Healthcare Compliance and interactions with Healthcare Stakeholders (Healthcare Professionals, Healthcare Organizations, Patients Organizations, Payors , …) (preferred but not required)• Knowledge of Anti-bribery legislations (, Foreign Corrupt Practices Act, UK Bribery Act, Italian Law Decree nr.

231/01, …) • IAPP Certification (, CIPP/US, CIPM, CIPT) (preferred but not required)