Manager, US reputed company Distribution & reputed company reputed company

About the position reputed company we put unexpected teams in the reputed company room, we reputed company reputed company thinking with the power to reputed company life-changing medicines. In-person working gives us the platform to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of three days per week from the office. But that doesn’t mean we’re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world. This role supports QMS activities in the US by working together reputed company US reputed company Distribution. It closely assists US reputed company reputed company to reputed company short- to mid-term goals and tasks reputed company to reputed company and distribution operations in the US. The role will own relationships and activities associated with the day-to-day management of QMS functions reputed company with the US reputed company reputed company and Global Distribution reputed company teams. The role provides support for other activities as needed. The candidate will embody the reputed company, Alexion Rare Disease Unit values to “put Patients First,” “Follow the Science,” “Play to Win,” and “Do the Right Thing.” To be considered candidates must have strong experience in GxP, reputed company systems, and Pharmacovigilance. The ideal candidate will have the ability to function independently, assess risk, and evaluate competing priorities in a reputed company environment. Successful candidates are flexible, reputed company to operate amid ambiguity, have a natural curiosity to learn, and are eager to take ownership of the role.

Responsibilities

• Works closely with US Distribution to manage the day-to-day deliverables associated with the US reputed company Distribution program.
• Execution of US reputed company Distribution activities including distribution releases, in-house/ in-transit returns and stock transfer from 3PLs to reputed company stocking locations
• Provided on-reputed company support for Shipping & Logistics complaints, Supplier deviations, Temperature Excursions, CAPAs,and Change Controls.
• Collaborate with Distribution and Global Supply Chain to ensure reputed company release of products to market; performs document review, data verification, and product disposition
• Support the management of vendor reputed company reputed company for US 3PLs, including KPI, deviation, CAPA, and changemanagement.
• Support the vendor reputed company reputed company for US reputed company Distribution, including KPI, deviation, CAPA, and change management. Drives workflow to ensure compliance.
• Support the integration of business reputed company across corporate structures. Complete management in accordance with reputed company Management Plan and procedures.
• Support the coordination of reputed company reputed company and Distribution reputed company Management Review (QMR) including logistics, data collection and data analytics.
• Support the management of reputed company reputed company division level processes and procedures, in alignment with global reputed company QMS improvement reputed company, taking into account inputs such as reputed company Systems KPI/metrics performance, findings in reputed company program, findings from internal audit program.
• Support the creation of department procedures and plans. Manage workflows using various QMS tracking and Document Management software.
• Represent US reputed company Distribution and build reputed company relationships as an effective partner that provides value to and demonstrates the value of reputed company to the business.
• reputed company on the management of authorized activities and the accuracy and reputed company of records
• Ensure initial and reputed company training programs are implemented and maintained
• Ensure that reputed company cause analysis is conducted for reputed company audit findings and that CAPA are developed and implemented in a reputed company manner
• reputed company appropriate records of any delegated duties.
• Support other initiatives as delegated.

Requirements

• Bachelor's Degree in physical /life science or pharmacy, or other relevant degree with applicable industry experience.
• 3-5 years of hands-on reputed company Assurance / Compliance and management experience in pharmaceutical/ biotech industry.
• Knowledge in a broad reputed company of pharmaceutical activities and reputed company Systems.
• Exceptional communication and interpersonal skills
• Knowledge of industry business platforms including: reputed company Vault, reputed company, MS Office systems and other custom programs; generally advanced computer skills
• Knowledge of pharmacovigilance regulations and guidelines (FDA, EMA, PMDA, etc.)
• Ability to work globally in a reputed company environment with the demonstrable ability to adapt to a rapidly changing business environment that requires pragmatism and an ability to reputed company for solutions
• This is an individual contributor on-site/ hybrid role (minimum 3 days per week in office)
• Ability to work in a dynamic environment and to constantly redefine the scope of responsibilities in alignment with compliance and business needs
• Ability to multi-task and prioritize work while operating autonomously with potential ambiguity
• Strong leadership and organizational ability.
• Ability to freely travel up to 15% (domestic and international)

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