Manager, Supply Chain

职位描述

Gilead's mission is to discover, develop, and deliver therapies that will improve the lives of patients with life-threatening illnesses worldwide.

Manager, Global Clinical Supply Chain is a leader that who carries out leadership vision and directions while providing expertise for Gilead's global clinical trials. Works collaboratively within the department and with cross functional colleagues (e.g., Regulatory, Clinical Operations, Quality, PDM sub-teams, GSC, etc.) to develop strategies, meet project deliverables, and solve business problems. The position has end-to-end leadership and accountability for clinical supply management. Prioritizes and creates executable work plans to ensure on time in full, safe delivery of investigational medicinal products (IMP).

Has mature working knowledge of supply chain and experience working with GxP environment. Has strong cross-functional, multi-cultural awareness and communication skills in a fast-paced, global company.

FOCUSE AREAS:

· Interprets clinical study protocols and/or dosing schema. Translates the information to IMP demand and supply planning requirements, distribution strategies including depot inventory management.

· Performs demand and/or supply forecasting and planning with planning horizon of 9 to 18 months. Translate forecasts into clinical packaging and labeling (CPL) execution plans. Supports contract/quote reviews and purchase order and invoice reconciliations.

· Develops and implements depot and clinical site seeding and resupply strategies.

· Carries out operational/logistics strategies and works with Quality Assurance, and other functional groups to execute strategies that ensure on time and safe delivery of all clinical shipments.

· Collaborate with Logistics management and other members of GCSC, PDM and external partners to resolve shipping related issues. Escalates to senior leadership as needed.

· Supports the clinical development and PDM strategies working collaboratively within GCSC, Quality and other functional groups to develop clinical supply strategies and plan with the focus on delivering compliant, quality IMP to clinical trials globally on time in full.

· Ensures accurate inventory and records at depots through timely reconciliation.

· Keeps abreast of clinical supply incidents and issues. Reports and escalates issues as well as investigates root cause as appropriate.

· Performs tasks in Gilead systems (e.g., SAP, IVRS, QMS, etc.) to enable compliant and efficient progression of IMP through the supply chain.

· Authors SOPs and business process work instructions as per leadership direction and support.

· Supports regulatory filings and inspections.

· Maintains compliance of clinical supply deliverables for clinical study reports (CSR) and trial master file (TMF).

· Keeps abreast of all incidents related to shipment and reports trending to Quality Assurance and assists in creating CAPAs.

· Responsible for maintaining GDP, GMP, and global trade compliance. Maintains compliance to required training.

· Obtain and review quotes, approves purchase requisitions and invoices.

Knowledge:

• Able to develop solutions to a wide range of moderately complex problems, which require the regular use of ingenuity and innovation.

• Excellent verbal and written communication skills and interpersonal skills.

• Demonstrates good planning and organizational skills coupled with strong time management skills.

• Has an aptitude for working with computer systems to plan and manage supply chain requirements.

• Demonstrates strong analytical and problem solving skills.

• Demonstrates up-to-date knowledge of business operating systems, distribution requirements planning, production scheduling, Oracle/DB2/Access databases and Microsoft applications (e.g., Excel) as relates to business needs.

• Proficiency in ERP system software, with emphasis on Operations/Supply Chain functionality.

Basic Qualifications:

6+ years of relevant experience in related field and a BS or BA; or
4+ years of relevant experience and a MA/MBA.
Experience in pharmaceutical operations/cGMP environment highly desirable.

Key Job Responsibilities:

• Works on problems of a moderately complex scope where analysis of situation or data requires evaluation of identifiable factors.

• Manages operations and may manage tasks and performance of assigned group of staff in the Supply Chain department, in accordance with the budget.

• If responsible for personnel management, selects, develops and evaluates staff to ensure the efficient operation of the function.

• Responsible for implementing and providing input to the planning of activities related to the material purchase, material control, inventory control, and shipping/receiving and stores functions, in support of Gilead’s existing and future business plans.

• Works on material schedules and coordinates the efficient movement of materials with production and engineering. Provides business solutions in support of Supply Chain planning.

• Maintains and assists with the implementation of Supply Chain policies, procedures, techniques, standards, and systems. Contributes to the development of complex new concepts, techniques and standards.

• Assists with the preparation of project plans and manages projects to successful and timely completion. Provides expertise to the team and functional areas to anticipate and identify complex project issues which pose a challenge to achieving strategic goals.

• Reviews and assists with planning requirements for business operations. Acts as an advisor to meet schedules and/or resolve technical problems.

• Supports the execution of supply chain planning initiatives to achieve departmental targets.

• Develops and maintains documentation to reflect the effectiveness and efficiency of department activities. Simplifies externally-facing documentation to the benefit of customers. Assists in the review and editing of complex regulatory documents.

• Negotiates contracts with suppliers/vendors to secure best pricing for the business. Monitors and reports the cost, schedules and performance aspects for contracts.

• Analyzes systems and processes and impact on business performance. Develops tools needed to support division Center of Excellence Service Teams action.

• Frequently collaborates with other departments, to ensure functional area resources are sufficient to achieve project goals and objectives.

• Acts as a relationship manager for cross-functional or external contacts. Involved in the earliest stage of partner relationships to help build solid foundations for collaboration.

• May recommend and assist with the integration of new technologies and/or new processes as needed, to reduce costs.

• May assist in the development of operational functional requirements and business process flow architecture of ERP functions and features, in support of Gilead’s existing and future business plans.