Project Manager - Analytical Quality and Compliance

Posted 05 October 2021
Job type Limited
DisciplineLife Sciences

Job description

Your Missions

The Project Manager will support the department activities related to an enterprise-wide initiative to update, harmonize, and integrate global procedures.

The Project Manager will provide the following support for the department's role in an enterprise-wide initiative to update, harmonize and integrate global procedures.

Your Responsabilities

  • Define/communicate clear deliverables
  • Track all deliverables
  • Gather input from various sources - QMS integration team, the department representatives to level 2 process optimization teams, The department leadership, and staff
  • Facilitate interactions/communication between process optimization teams to prevent silos, overlaps, gaps because different level 2s will be optimized at different times (risk-based) by different core teams
  • Communication plans; educate and engage stakeholders
  • Perform program and time management activities

Your Profile

  • BS/BA in a life science field
  • Minimum of 5 years professional experience in Quality Assurance, Quality Control, analytical chemistry, method development in the small molecules or biologics spaces
  • Previous experience in QC laboratory and in QA roles
  • Previous experience using electronic document and quality management systems (i.e., DCA, Veeva, PDLIMS, TrackWise)
  • Experience with QC testing procedures for small molecules and biologics
  • Experience in a GMP environment
  • Experience with the change control process, action plan evaluation, and coordination of change control progress within assigned areas of responsibility

Aymeric Shimamungu is your Kelly contact for this role. Please apply online