Global Clinical Materials Manager

Global Clinical Materials Manager (f/m/d)

Global Clinical Materials Manager (f/m/d) - GMP /SAP ERP / Six Sigma / SOP / SAP Clara P96

Project:
For our customer a big pharmaceutical company in Kaiseraugst we are looking for a highly qualified Global Clinical Materials Manager

Background:
As part of PTDS Global Clinical Supply Chain Management, the Production Enablement function ensures that packaging operations can produce material required by clinical trials seamlessly, on-time, and while optimizing cost/quality.

Within Production Enablement, the Global Clinical Materials Manager (GCMM) leads the coordination and execution of all procurement activities of drug products and packaging materials for global clinical studies. This includes the coordination of the release of these materials to ensure a timely production of Investigational Medical Products in accordance with international standards and regulatory requirements. Furthermore, the GCMM is responsible for all tasks related to clinical demand planning of packaging material.

The perfect candidate:

The perfect candidate is a person with a strong Customer-focused ability to create trustful relationships with business partners. Additionally, he/she has the ability to work independently, set priorities and is a Self-motivated, proactive, quick-thinking personality.

Tasks & Responsibilities:**

Single point of contact to ensure availability of drug products and packaging materials to clinical manufacturing. This contains the following responsibilities:

• Responsible for the correct master data maintenance of all drug products and packaging materials
• Compile product-specific data and documents for drug products and packaging material
• Define, request and continuously update the master data of drug products and packaging materials in SAP-systems
• Plan packaging materials in SAP-systems
• Manage purchase orders for Roche development drug products, "Roche-Partner" drug products, Roche commercial drug products and external commercial drug products from internal and external suppliers in the appropriate procurement system
• Manage purchase orders for packaging materials in the appropriate procurement system
  Supplier Relation Management: Manage various drug product- and packaging material suppliers to the Clinical Supply Chain Organization, incl. creating suppliers performance transparency with KPIs and taking applicable actions for continuous improvements
• Support of warehouse in goods receipt questions
• Perform virtual goods receipts
• Responsible for ensuring batch availability of drug product and packaging materials for further manufacturing
• Manage the compilation of a GMP- and customs-compliant goods receipt dossier for the QA-release of drug products and packaging materials
• Maintain GMP and non-GMP-batch data of drug products and packaging materials in SAP
• Ensure the on time QA-release or AFM ("Authorization for Further Manufacturing") of drug products and packaging materials
• Handle shelf-life extensions
• Manage the shelf-life extensions of packaging materials at batch level
• Manage the shelf-life extension of drug products at material and batch level including the associated documentation
• Drive and lead the issue management for global clinical supply concerning the procurement of drug products and packaging materials as well as the goods receipt of drug product
• GMP Deviation- and Change Management
• Actively support inspections
• Actively monitors Key Performance Indicators (KPIs) for team- and vendor-performance and works independently to develop ideas and initiates continuous improvements
• Lead and participate in global / local projects to optimize Clinical Supply processes
• Collaborate with Business Process Managers to exchange ideas, drive process improvement, and resolve issues on both global and local level.
• Support system improvements, create and update SOPs and other department/training documents which support daily business
• Works independently on system improvements in SAP CLARA P96

Must Haves:

Associate level of professional education or University degree in the pharmaceutical, biopharmaceutical or Supply Chain Management, or a Master's Degree

• 1-3 years' experience in the pharmaceutical, biopharmaceutical industry and/or Supply Chain Management
• User Experience with SAP ERP systems
• High cultural awareness and social competence required as cooperation and communication in complex situations with different cultures and countries is part of the daily job.
• Well-developed teamwork, collaboration, and negotiation skills
• Possess strong problem solving and decision making skills, high attention to detail, and understanding of systems and technical designs
• Ability to adhere to procedures and standards in a GMP environment
• Ability to manage projects from initiation to delivery
• Ability to work independently and set priorities. Self-motivated, proactive, quick thinking, adaptable.
• Ability to communicate clearly and professionally both in writing and verbally (Excellent English skills - German basic skills beneficial)
• Customer-focused, ability to create trustful relationships with business partners.
• Ability to quickly learn a broad range of skills

Nice to Have:

• PMP/Operational Excellence/Six Sigma/Lean training a plus
• Experience with MyBuy system preferred
• APICS and/or SCOR certification, or equivalent relevant experience

Reference Nr.: 922932SGR
Role: Global Clinical Materials Manager
Industry: Pharma
Workplace: Kaiseraugst
Pensum: 100%
Start: 01.12.2023
Duration: 12++

Deadline : 11.10.2023