Description:
Responsibilities include, but are not limited to:
Trade Compliance
- Responsible for and an expert in all global trade activity within Alexion Pharmaceuticals
- Develop strong partnerships with a broad global stakeholder base and will ensure that timely Global Trade information and analysis is available and published on an agreed regular cadence
- Proactively identify changes in internal and external business trade conditions which will impact upon the global demand network model and quickly ensure that required changes are put in place
- Provide guidance to Alexion Global Supply Chain, Clinical, Finance and other departments within Alexion on trade compliance issues and questions
- Coordinate with and communicate import and export regulatory and process requirements to other departments within Alexion
- Lead the development and update of global trade compliance processes and valuations ensuring compliance in all markets together with identification of opportunities to reduce operating costs
- Perform compliance checks on import and export day-to-day transactions in accordance with Alexion Global Operations policies and procedures.
- Identify opportunities to streamline and improve trade compliance processes. Work with the business units to implement potential improvements
GDP Compliance
- Supporting all aspects of GxP compliance within the Supply Chain Operations organsiation to include - training, metric governance, GxP record management to ensure the team are proactively “Inspection Ready”
- Lead matrix Product Security team across the Alexion Rare Disease Business Unit
- Collaborate with critical business partners including but not limited to, Quality, Global Logistics & Trade, Commercial Operations, Contract Manufacturing, Regulatory, Legal, Market Access to mitigate risk across the supply chain; in conjunction with these stakeholders, manage CTPAT, AEO, ISO, TAPA, Falsified medicines program and other voluntary supply chain security initiatives beneficial to Alexion operations.
Required Experience / Qualifications
- 5+ years of experience in a similar role.
- Substantial prior experience and technical expertise in all aspects of pharmaceutical import/export compliance and Export Administration Regulations
- Past experience in interfacing with regulatory authorities
- BA/BS Degree
- Proficient in Microsoft Word, Excel, and Access
- Strong organizational skills
- Strong leadership, presentation, and communication skills.
- Ability to develop internal and external relationships.