Clinical Supply Chain Coordinator / Planner

Newark, CA 94560

Posted: 10/23/2018 Employment Type: Direct Hire Industry: Clinical & Scientific Job Number: 14072
Position Summary:
Seeking a  highly motivated Supply Chain  professional  with  clinical/commercial  supply management experience to join  Revance  as a Supply Chain Coordinator / Planner.  This position  will support the supply chain  function  for current  and upcoming  clinical  packaging and labeling needs, as well as  future commercial operations  activities.   The  Supply Chain Coordinator / Planner  ensures the performance of thesupply chain from order to  distribution (source, make, deliver).   The Supply Chain Coordinator / Planner  works in a capacity of overseeing a variety of channels within the supply chain to ensure that the overall process runs smoothly  and within identified timelines.

Essential Functions:

 

GMP  Compliance
  • Prepare and track deviations and CAPAs; Recommend permanent solutions to resolve recurring problems that result from deviations and CAPAs. 
  • Resolve issues in a timely and efficient manner. Anticipate and defuse any potential problems.  Apply independent judgment, analytical problem-solving skills to situations to maintain quality and company standards.
  • Participate in Inspection Readiness effort, ensuring Supply Chain compliance is fully prepared for both internal and external audits.
  • Partner with  Clinical  Operations, Manufacturing,  Quality  Assurance, Quality Control to maintain Good Documentation Practices (GDPs) that comply with company standards. 

 

Clinical Supply Chain
  • Plan,  schedule,  and manage inventory  and logistics of clinical studies (secondary packaging and labeling activities).   Ensure projects  are on track  and the final approval of products are moving through the production cycle.
  • Manage timelines  during the execution phase of clinical trials consistent with GCP guidelines and executing supply strategies in view of changes in trial execution. 
  • Utilize  business tools/systems  to monitor inventories and ensure  on-time delivery with minimal overage of supplies. 
  • Ensure batch release  and retest  dates are properly prioritized for packaging and labeling timelines.  Maintain  awareness of  productexpiration dates a well as supply levels  to meet the needs of multiple sites, trials and patients.  Manages / resolves situation if contingent plan needs to be developed.
  • Partner with Clinical  Operations  to identify and fulfill  supply demands.

 

Clinical Packaging and Labeling
  • Create, review and update clinical supply packaging plans to meet the demands of multiple clinical trials.
  • Determine label requirements and based on those requirements, create clinical trial material  proof  labels and create and maintain the approval process and label controls.    
  • Perform project manager role and collaborate and develop excellent working relationships across internal functional groups and external vendors (CMO, CRO) to ensure timelines are met. 
  • Manage supply chain timeline and stays abreast on changes  by the functional groups or external vendors.   Analyze  and assess the downstream impact of those changes and determines a solution.
  • Resolve shipping issues that come up and investigates the root of the problem.  Recommends solutions to resolve issues (i.e. labeling issues, QA issues due to temperature deviations, translation requirements).
  • Ensures comprehensive compliance with material requirements.
  • Manage and track budgets.  Place  purchase orders and track supply specific budget against invoices during trial/project execution. 

 

 

Materials Management
  • Place purchase orders  for raw materials/consumables to ensure  supply  for manufacturing  execution. 
  • Plan,  schedule,  and manage inventory  and logistics to help manage supply chains.
  • Write, review, and update SOPs to ensure process improvements are captured and ensure GMP compliance.
  • Responsible for reading  documents for periodic review and  suggest new ways of managing the supply chain at Revance (work flow, etc.)
  • Participate  in the sourcing of second source  suppliers/materials as needed.
  • Partner with Commercial Operations to support future S&OP process.
  • Participate in ERP implementation.
  • Provide back-up support to warehouse personnel.

 

 

 

Required  Experience / Knowledge:
  • Minimum of 5+  years of experience in supply management and logistics in biotech/pharmaceutical industry
  • Proficient in cGMP’ s, pharmaceutical industry procedures,  FDA and EMEA regulations
  • General understanding/knowledge of GxP
  • Knowledge of Good Documentation Practices (GDPs) that comply with company standards
  • Knowledge of clinical supply demand management/planning tools (e.g. IVRS) or equivalent supply chain planning systems (SAP/ERP) and ability to support IVRS set up and maintenance
  • Experience with clinical trial material label proof creation, approval process and label controls
  • Manage several projects simultaneously to quality, budget and schedule constraints
  • Proven ability to work in cross functional teams to execute projects  and strong interpersonal  Excellent
  • Detail oriented and flexible with  the ability to manage change
  • Exceptional verbal and written communication skills, solid organizational, time management and project management skills
  • Prior experience exercising independent judgment, analytical and problem solving skills
  • Must be competent  with the Microsoft Office suite of products, knowledge of ERP and document Control systems a plus

 

 

Required  Education:
  • Bachelor’ s  degree  or equivalent work experience in Materials Management, Supply Chain, or related discipline

Jesse Ashworth

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