Remote Quality Lead Jobs

Insight Global is looking to hire a fully remote Quality Lead To strengthen our largest pharmaceutical client's European External Supply Integration (ESI) Drug Product team, we are looking for services to support assuring timely delivery of drug product supplies and clinical trial material from the PPDS Contract Manufacturing Organization (CMO) network. The External Supply Integration (ESI) is responsible for the successful technology integration, production as well as delivery of clinical supplies according to GMP regulation for DP at external sites.

Fully remote, northeast US preferred to meet F2F at CMO occasionally

They will be expected to be at site and partner with CMO and team/functions to assure all logistical, quality & technical elements are in place for right first-time delivery of clinical material. They will work with CMO to provide technical and operational guidance to improve and to assure site readiness including Process Fit to Plant, scale-up and technology transfer.

As part of the EU ESI team, the major assignment for this challenging and versatile role covers the following:

• Support implementation of new enabling technologies and manufacturing platforms as well as supporting the establishment of new supply chain routes
• Be part of global project teams with members out of different disciplines and with different function
• Support to assure all logistical, quality & technical elements are in place for clinical manufacturing at the respective CMOs
• Bring in process engineering expertise to support development and technology transfer of robust and lean processes at the interface towards the development organizations
• Support to ensure drug product supplies and assuring timely delivery of clinical trial material • Building and implementing Key Performance Indicators & Performance Matrixes for the EU CMO network
• Focus on continuous improvement and cost saving initiatives at different CMOs and locations

Qualifications

• A degree (BE/MS/PhD) in (life) science, chemical engineering, bio engineering, pharmaceutical technology or chemistry is preferred
• Basic understanding of Clinical Manufacturing, Process Engineering & Scale-up, Pack &Label and Process Analytical Technology is preferred. Knowledge of Cleaning and Process Validation, Technical Safety and Industrial Hygiene Standards, elementary knowledge of Facility, HVAC and Utility design & concepts is an advantage
• Preferred to have at least 5 year working experience in Oral Solids and Liquid Process Technology. Knowledge of Sterilization Technology, Parenteral Processes including Fill/Finish is an advantage
• Very good process management skills, Lean and Six Sigma qualifications preferred
• Preferred to understand new product/process introduction
• Shown capability to handle multiple projects in parallel - Being able to influence partners in an international environment without line authority
• Good understanding of ICH, cGMP, regulatory and other pertinent manufacturing and engineering guidelines and practice
• Creativity and the ability to develop a flexible approach to changing conditions