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Analytical Quality & Compliance Program Manager

Ref: JN-092021-195463

Publié le 24 September 2021
Sciences de la vie

Modis Life Sciences (The Adecco Group) is looking for one of it's client a:

Your Responsibilities:

  • Define/communicate and track all deliverables
  • Gather input from various sources : QMS integration team, site representatives optimization teams, 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
  • Provide feedback as needed
  • 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
  • Knowledge of QC, QA, analytical method development or method validation functions
  • Understanding and knowledge of FDA, ICH, and USP guidelines and GxP regulations
  • Excellent communication skills, attention to detail, relationship management skills, negotiation, problem-solving and personal time management skills
  • Ability to manage multiple priorities with aggressive timelines
  • Project/program management skills
  • Knowledge of quality management system
  • Experience with QMS integration is a plus
  • People change management skills: ability to influence and engage individuals and groups