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Sr. Manager / Associate Director, Clinical Supply Chain Management - Pharmaceutical

Grimaldi Staffing Services South San Francisco, CA
  • Posted: 1 day ago
  • Other

Summary

The Sr. Manager / Associate Director, Clinical Supply Chain Management will manage global supply chain and distribution of drug products for all on-going and new clinical programs at the company. This individual will oversee supply chain management activities including: planning and coordinating packaging, labeling, distribution, reconciliation, and destruction of drug product for clinical studies. The Sr. Manager / Associate Director will interface between clinical, CMC and external CROs to actively develop and manage process ensuring timely, accurate and continuous supply to patients while reducing risk and minimizing waste.

Key Responsibilities

  • Work with Clinical Operations to understand clinical demand requirements and ensure alignment with CMC to supply plans and timelines
  • Manage GMP inventory (both drug product and drug substance) throughout the supply chain, develop inventory reports, manage upcoming expiry and temperature excursions, and ensure drug accountability
  • Support the evaluation, selection and quality audit of packaging/labeling and distribution vendors
  • Coordinate daily activities with distribution vendors as required
  • Serve as internal lead for triaging of product complaints, temperature excursions, and deviations originating from distribution vendors and clinical sites.
  • Investigate deviations to determine root causes and implement corrective actions
  • Ensure label text and proofs are in accordance with applicable regulations, product specifications, and clinical study protocols
  • Support IRT user acceptance testing, supply strategy, and oversee ongoing supply activities in system
  • Coordinate import/export activities and track shipments to depots and clinical sites.
  • Ensure all necessary documentations are available to the clinical sites
  • Develop supply chain management strategies to maximize supply efficiency, minimize waste while identifying risk and develop risk mitigation plans
  • Work with QA/QC to establish internal SOPs for supply chain management related activities

Qualifications include:

  • M.S. or B.S in scientific or health related field with 8+ years’ experience in Clinical Supply Chain Management in biotech or pharmaceutical industry
  • Understands comprehensive global pharmaceutical regulatory requirements (e.g. cGMP, GDP, and GCP)
  • Knowledge of IWRS/IRT system setup and functionality and proficiency with Excel modeling
  • Knowledge and understanding of international pharmaceuticals shipping requirements
  • Self-motivated, comfortable in fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
  • Effective communication, interpersonal skills, collaboration and negotiation skills
  • Highly organized and efficient, able to orchestrate multiple projects simultaneously

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Grimaldi Staffing Services

Address

South San Francisco, CA
USA

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