Transfer Manager (m/f/d)

For our customer from Rhineland-Palatine we are searching from 09/2023 for a Transfer Manager in part time (m/f/d) – 80% remote possible.

Your tasks:
- Technical advice to the customer regarding the composition of the project team
- Manage project and coordinate all transfer activities including Chemistry Manufacturing Control (CMC)-upgrades required for registration (defined by the customers Regulatory Affairs)
- Coordinate gap assessments and risk assessments to refine scope
- Define actions to meet refined requirements for approval by the costumer
- Plan and document actions in respective project plan
- Coordinate those actions by tracking actions in project meetings
- 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)
- Evaluate resource demand for transfer project and report to project lead if demand arises
- Initiate creation of a Control Strategy Summary (CSS)-DP Update of the global CSS-DP for the new manufacturing site

Your qualification:
- Years of experience in management of interdisciplinary teams in international context
- 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
- Business fluent English (mandatory), German language (beneficial)