Program Manager H/F

☞ Interima

View: 132

Update day: 24-04-2024

Location: Neuchâtel Neuchâtel NE

Category: Pharmaceutical / Chemical / Biotech

Industry:

Job type: Temps plein, Durée déterminée

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Job content

INTRODUCTION:

On behalf of our client, a recognised company based in Neuchâtel, we are currently looking for a


Program Manager (H/F)


DESCRIPTION DE LA MISSION:

Program Manager – Harmonization and Integration Initiative


The Project Manager will support the GQAS&T 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. This is a role that requires the ability to quickly learn and understand the department’s processes to determine impact from the global initiative and ensure that the department can effectively respond and adapt to changes

Details

  • Define/communicate clear deliverables for GQAS&T
  • Track all GQAS&T deliverables
  • Gather input from various sources – QMS integration team, GQAS&T representatives to level 2 process optimization teams, GQAS&T 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 outside GQAS&T as needed
  • Communication plans; educate and engage stakeholders
  • Perform program and time management activities

PROFIL ATTENDU:
  • 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 or 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
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Deadline: 08-06-2024

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