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Pharma Project Manager (m/f/d)

Industry
Pharmaceutical
Area
Project Management

Project info

  • Period
    01.09.2023 - 30.08.2025
  • Capacity
    40 - 50%
  • Daily rate
    800 - 880€
  • Location
    Inglheim, Germany
  • Remote
    up to 80%

Description

  • Draft a team setup for a transfer team by defining required skills and stakeholders based on requirements and the contractor’s expertise. BI will allocate team members to the project based on this draft.
  • Manage the project and coordinate all transfer activities, including Chemistry, Manufacturing and Control (CMC) upgrades required for registration (as defined by BI Regulatory Affairs).
  • Define scope based on predefined requirements.
  • Coordinate gap assessments and risk assessments to refine the scope.
  • Define actions to meet refined requirements for BI approval.
  • Plan and document actions in the project plan.
  • Coordinate these actions by tracking them in project meetings.
  • Document results in the project plan.
  • Present results to BI (Steering Committee).
  • Trigger and follow up on the consolidation of the initial Stock Keeping Unit (SKU) Transfer Master List (STML) and the creation of new global SKUs.
  • Organize and lead regular project team meetings, document decisions and follow up on action items.
  • Create, track and update the project plan (work packages and timelines, typically shown as a Gantt chart).
  • Evaluate resource demands for the transfer project and report to the project lead if additional resources are needed.
  • Escalate critical issues to BI.
  • Prepare and distribute a Circular Letter to inform stakeholders about the transfer.
  • Draft the Circular Letter using defined templates and project results.
  • Hand over the draft to BI for review.
  • Finalize the Circular Letter based on the review.
  • Submit the document to BI for final review and approval.
  • Distribute the Circular Letter to the defined stakeholder group, clearly showing that the contractor is external and is sending it on behalf of BI.
  • Initiate the creation of a Control Strategy Summary (CSS)-DP update for the new manufacturing site.
  • Draft the CSS-DP update using defined templates and project results.
  • Hand over the draft to BI for review.
  • Finalize the CSS-DP update based on the review.
  • Submit the document to BI for final review and approval.

Requirements

  • At least 5 years of experience managing interdisciplinary and virtual teams in an international context
  • Pharmacist or similar background with hands-on experience in managing manufacturing transfers (drug product bulk and packaging)
  • Strong, state-of-the-art project management skills; certification in new methodologies (e.g. agile tools) is a plus
  • Deep knowledge of international regulations and standards (e.g. EU GxPs, FDA), compliance with manufacturing and quality standards, and specifics for human pharma products
  • Excellent communication skills; fluent English (mandatory), German (beneficial)
  • Customer-centric and quality-oriented mindset; financially reliable