Manager, Supply Chain

Manager, Supply Chain

United States - California - Foster City Manufacturing Operations & Supply Chain Regular

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 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.

• 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.

• 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.

• 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…