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Project Manager Pharma (m/w/d)
Industrien
Gesundheitswesen
Informationstechnologie (IT)
Pharmazeutika
Bereichen
Betrieb
Informationstechnologie (IT)
Produktentwicklung
Projektemanagement
Projekt Info
Dauer
01.09.2023 - 30.08.2025
Auslastung
40 - 50%
Tagessatz
800 - 880€
Standort
Inglheim, Deutschland
Sprachen
Remoteanteil
Bis zu 80%
Beschreibung
Draft a team set up of a transfer team by defining required skills and stakeholders based on respective requirements and the contractor’s expertise. Based on this draft BI will allocate team members to the project.
Manage project and coordinate all transfer activities including Chemistry Manufacturing Control (CMC)-upgrades required for registration (defined by BI Regulatory Affairs)
Define scope based on the pre-defined requirements
Coordinate gap assessments and risk assessments to refine scope
Define actions to meet refined requirements for approval by BI
Plan and document actions in respective project plan
Coordinate those actions by tracking actions in project meetings
Document results in project plan
Present results to BI (Steering Committee)
Trigger and follow up consolidation of initial Stock Keeping Unit (SKU) Transfer Master List (STML) and creation of new global SKUs
Organize and moderate regular project team meetings including documentation of decisions and follow-up of action items
Create, track and update project plan (specification of work packages and timelines; typically depicted as Gantt chart)
Evaluate resource demand for transfer project and report to project lead if demand arises
Escalate critical issues to BI
Prepare and distribute Circular Letter to inform stakeholders about transfer
Draft a Circular Letter by using defined templates and results of the project
Handover the draft to BI for review
Based on the review, finalize the circular letter
Hand over the document to BI for final review and approval
Distribute the Circular Letter to defined stakeholder group, clearly recognizable contractor is an external and is sending on behalf of BI
Initiate creation of a Control Strategy Summary (CSS)-DP Update of the global CSS-DP for the new manufacturing site
Draft a CSS-DP Update by using defined templates and results of the project
Handover the draft to BI for review
Based on the review, finalize the CSS-DP Update
Hand over the document to BI for final review and approval
Anforderungen
At least 5 Years of experience in management of interdisciplinary teams in international context and managing virtual teams
Pharmacist or comparable background with specific work experience in Management of Manufacturing Transfers (Drug Product Bulk and Packaging)
Strong state of the art Project Management skills; certification in new methodologies (e.g. agile management tools) beneficial
Profound knowledge of international regulations and standards: e.g. EU GxPs, FDA, Compliance with manufacturing and quality standards, and the specifics for Human Pharma products.
Excellent communication skills, English fluent (mandatory), German language (beneficial)
Customer centricity and quality -oriented mindset, financial reliability