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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