Sr Manager, R&D Quality Project Improvement Leader, Risk Management
Offer type: full time
Location: New Jersey - Bridgewater
The Quality Project Improvement Leader (QPIL) leads large transversal projects for which significant changes/improvements to business processes are expected across R&D and beyond, as applicable. He/she leads continuous quality and performance improvement through optimized processes, new technologies and innovation. The QPIL leads the project and is accountable for the planning and delivery of the project, with the expected quality and within budget and resources. He/She leads in the business process definition utilizing BPM methodology to analyze processes, identify opportunities for optimization, defines appropriate Key Performance Indicators and implementation of a business process governance, framework and culture. QPIL leadership will work in alignment with the R&D LEAN program as it is essential for the creation of enduring and sustainable businesses in a highly competitive world. The QPIL is responsible to lead the creation/revision of operational reference standards and the associated training plans which will facilitate implementation of the new business process and to reduce business continuity risks. These deliverables are part of those standards which are required by Regulatory Authorities for compliance to Good Clinical Practice (GCP) and related regulations (which is essential to compliance in the conduct of international clinical trials performed by the Company). He/She will lead, via a project management approach, large transversal project working collaboratively with other functions. The QPIL will work with the team to identify and analyze trends and identify and escalate appropriate clinical quality risks. The QPIL is an “expert”/leader representing the Q&CI Department for the transversal working groups which are established to develop or revise business processes and identify strategic solutions for improvement and in the process for gathering, analyzing and sharing of best practices and lessons learned.