Amalia Crescenzio

• Led successful audits and examinations, demonstrating the company''s commitment to transparency and accountability.
• Lead the enterprise-wide compliance performance, overseeing the Dompé Global Compliance program with regard to Healthcare Compliance (“HCC”) and Anti-bribery Anti-Corruption (“ABAC”).
• Collaborated with legal, accounting and other professional teams to review and maintain compliance with regulations.
• Identify potential risks through counseling/monitoring/auditing activities and assisting with such activities as appropriate.
• Provide Compliance advice to Sr. Management and respond to employee inquiries regarding compliance regulations and procedures.
• Develop and execute reporting to the Sr. Management.
• Develop Training and Audit Plans.
• Acting as chair of the Investigation Committee reviewing and, where appropriate, acting in response to reports of noncompliance.
• Implement improvement initiatives and developed compliance testing program to monitor and identify gaps in new and existing practices.
• Collaborate with sales and marketing departments and other business units to address indications of improper sales practices and market conduct violations.

• Develop and establish the EMEA HCC program in alignment with the Global HCC program.
• Identify potential HCC risk areas and ABAC issues
• Establish and implement remedial activities interacting with applicable affiliates, departments and functional heads
• Act as member of the Management Team, the ABAC Steering Committee and on the Corporate Policy Committee
• Member/leader of cross-functional teams that perform HCC compliance investigations.
• Act as a team leader in group projects, delegating tasks and providing feedback.

• Lead the country-based Compliance Managers, implement and administer Amgen's Corporate compliance programs & policies and compliance framework
• Review risk assessment, investigation, monitoring and audit outcomes in the countries and work together with Compliance Leads / Managers on corrective actions implementation.
• Evaluated employee performance and conveyed constructive feedback to improve skills.
• Achieved operational excellence by streamlining processes and implementing best practices.
• Led cross-functional teams to achieve project milestones and deliver high-quality results.
• Established performance goals for employees and provided feedback on methods for reaching those milestones.

• Implement and administer within the region/HQ site Amgen's Corporate compliance programs & policies and International compliance standards & procedures.
• Review risk assessment, investigation, monitoring and audit outcomes in the region/HQ site and work together with Compliance Leads on corrective actions implementation.
• Identify the need for specific International compliance controlled documents and procedures and lead/support their development and implementation.
• Understand Compliance and Business drivers and strategy and act as advocate for Compliance within the business.
• Contact point for healthcare compliance advice within HQ or region.
• Interact with and successfully influence all levels of staff in the region/HQ site to accomplish compliance initiatives and goals.
• Support Large European Countries and CEE Affiliates in developing training activities trough electronic platform
• Evaluated employee performance and conveyed constructive feedback to improve skills.
• Leveraged data and analytics to make informed decisions and drive business improvements.

• Lead of functional healthcare compliance projects and processes in Italy

Ensure smooth communication and best practices sharing within South Region (Portugal, Spain, France, Netherland, Greece)
• Lead of functional healthcare compliance projects and processes.
• Provide Compliance advices for internal clients
• Lead South Region risk assessment exercise
• Assist South Region Affiliates in implementing and administrating Company's Compliance programs and policies and Int'l Compliance Standards and procedures
• Identify needs for South Region Compliance procedures, lead their development and implementation

• Ensure compliance with Quality (GMP/GDP) regulations and Amgen procedures as applicable for affiliate.
• Quality system management.
• Create GMP/GDP procedures based on European guidelines for use by all Amgen Int'l Affiliates.
• Create training program and relevant materials for quality and healthcare compliance processes.
• Handle Quality-related interface with customers (product complaints, recalls).
• Create training program and relevant materials for quality and healthcare compliance processes.
• Define audience.
• Lead face to face trainings.
• Completed supporting documentation for testing procedures, data capture forms, equipment logbooks and inventory forms.

• Initiated the secondary packaging manufacturing site with AIFA (Italian Regulatory Agency)
• Managed Quality system.
• Develop GMP/GDP procedures based on Italian guidelines for use by logistic.
• Evaluate quality agreements in accordance with local requirements for providers and Pharmaceutical Customers.
• Perform Third Parties Audits .
• Managed Import/Export (int'l) and distribution (locally) of narcotics

• Ensure compliance with Quality (GDP) regulations
• Manage distribution of narcotics locally
• Manage and maintain relationships with pharmacists
• Project Manager Telemarketing
• Responsible for the returned goods department

• Ensure compliance with Quality (GDP) regulations
• Manage distribution of narcotics locally
• Manage and maintain relationships with pharmacists
• Project Manager Telemarketing
• Responsible for the returned goods department