KalVista Pharmaceuticals
Sr. Manager/Associate Director, Logistics & Trade Compliance
KalVista Pharmaceuticals, Framingham, Massachusetts, us, 01704
Framingham, US
About KalVista Pharmaceuticals, Inc.
KalVista is a global pharmaceutical company dedicated to delivering life-changing oral therapies for individuals affected by rare diseases with significant unmet needs. The KalVista team discovered and developed EKTERLY—the first and only oral on-demand treatment for hereditary angioedema (HAE)—and continues to work closely with the global HAE community to improve treatment and care for this disease around the world.
Ekterly (sebetralstat) is a novel plasma kallikrein inhibitor approved in the United States, European Union, United Kingdom and Switzerland for the treatment of acute attacks of hereditary angioedema (HAE) in people 12 years of age and older. Ekterly is the first and only oral on-demand treatment for HAE, offering efficacious and safe treatment of attacks without the burden of injections. With ongoing studies exploring its use in children aged two to 11 and multiple regulatory applications under review in key global markets, Ekterly has the potential to become the foundational therapy for HAE management worldwide.
KalVista seeks an experienced professional to support the Logistics & Trade Compliance function. In this role you will have responsibility for managing day-to-day logistics and have oversight of KalVista’s Trade Compliance within the Global Supply Chain organization. You will report to the VP, Global Supply Chain. This is an excellent opportunity to evolve this function to support the upcoming launches and advance the overall Supply Chain capabilities to deliver therapies that transform the lives of patients.
Responsibilities :
Build and manage logistics operations for optimal quality, safety, environmental sustainability, cost-effectiveness, and asset utilization
Lead the logistics operations in a global, harmonized manner with execution in a decentralized way
Ensure all company’s logistics operations are conducted in compliance with US and foreign trade laws. Lead/primary representative in customs audits, inspections, and regulatory agency inquiries
Partner closely with Tax, Finance, Manufacturing to provide strategic and operational input into supply chain decisions
Investigate and develop strategy and response to ensure compliance in accordance with appropriate laws and regulations
Develop policies, SOPs, and Work instructions relevant to Logistics & Trade Compliance
Qualifications :
Minimum of 5 years’ experience within logistics, Distribution (GDP), and supply chain in the pharmaceutical industry and in a virtual manufacturing/supply environment
Minimum educational requirement is a BS or a BA
Experience with Import/Export of Drug Substance & Drug Product
Experience with product HTC classifications, valuation, and Country of Origin determinations
Global operations experience, import / export operations, working knowledge of regulatory, drug licensing, and operating requirements in a global market
Hands-on experience in Logistics, trade compliance
Effective communication, presentation, decision making, influencing and negotiation skills
Extensive acumen in problem solving, managing priorities and commitment to quality & safety
KalVista is an equal opportunities employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
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