Associate Director Global Clinical Supply Chain Logistics Lexington, MA

Associate Director Global Clinical Supply Chain Logistics

 
Job ID: Job-1899       
Job Title:      Associate Director Global Clinical Supply Chain Logistics      
location:       Lexington, MA  
Jobtype:        Permanent      
       
Description:    Provide leadership and direction to facilitate planning and execution of Clinical Supply Chain activities globally. Will oversee operations including clinical packaging, labeling, and distribution. Also responsible for developing and formalizing robust processes/procedures related to Clinical Supply Chain activities in compliance with global regulations. 

Requirements 
Bachelors Degree required with (8+ years) Vendor Management and People development skills. 
5+ years People Management. 
Experience with regulatory submissions is a plus. 

Responsibilities 
Manage Clinical Supply Chain Specialists 
Direct/oversee contract manufacturing packaging, labeling, and international shipping/distribution operations, ancillary kits, and devices ensuring on time delivery to support clinical trials. 
Act as primary liaison with contractor(s) (CMO’s). 
Work with Clinical Operations, QA and Regulatory to develop ancillary kits and label text for multiple countries/regions. 
Establish SOPs, protocols, and procedures for clinical trial material packaging, labeling and distribution to ensure compliance with cGxP requirements. 
Manage vendor selection for clinical study support, including Clinical Packaging and Labeling facilities, comparator sourcing and any others as required. Work with Regulatory Compliance and QA in selection/qualification of CMO's. 
Manage Quality Systems required documentation, including Deviations, Investigations, CAPA’s, Change Controls, Label and Product Specifications, and others as required. 
Develop and apply Project Plans and Schedules that represent the appropriate level of detail and task independency. 
Ensure timely follow-up to all commitments in a project plan. 
Proactively address risk management issues. 

Email resume in Word to TheBigGameHunter@cisny.com. Please include the job code for the position with your resume. 

NO RELOCATION. ONLY THOSE AUTHORIZED TO WORK IN THE US. VISA TRANSFERS ARE NOT AVAILABLE AT THIS TIME. NO 3RD PARTIES. NO OVERSEAS RESUMES, PLEASE. 

Watch and subscribe to TheBigGameHuntrTV on YouTube for ”No B.S.” job search and hiring advice. To receive a complimentary subscription to my job search ezine, No B.S. Job Search Advice, go to http://www.JeffAltman.com to subscribe. Receive tweets from Twitter with job search tips and job listings –@ TheBigGameHuntr