Job Description

Job Description:

• Majority of time in the office (49% Home office allowed)

Job title

• Global Clinical Materials Manager
• Department: PTDS-Global Competency Center Production Enablement
• Reports to: Head Global Clinical Materials Management
• Locations: SSF

Duties and Responsibilities, Interfaces:
Role Summary:

• As part of PTDS Global Clinical Supply Chain Management, the Production Enablement function ensures that packaging operations can produce material required by Roche’s 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.

Key Responsibilities
Main responsibility: 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 materials.
  • 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-

o Manage the compilation of a GMP- and customs-compliant goods receipt dossier for the QA-release of drug products and packaging materials

o Request and continuously GMP and non-GMP-batch data of drug products and packaging materials in SAP

o Ensure the on-time QA-release or AFM (“Authorization for Further Manufacturing”) of drug products and packaging materials.

• Handle shelf-life extensions-

o Manage the shelf-life extensions of packaging materials at batch level.

o Manage the shelf-life extension of drug products at material and batch level including the associated documentation.

• Confirm the quantities received to enable accurate cost charging of drug products and packaging materials in the relevant financial systems.
• 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

Job Requirements and Qualifications:
Competencies:

• Solid understanding of the Pharma Supply Chain and clinical packaging processes
• 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.
• Full use and application of basic Supply Chain/Business Process/cGMP theories, principles, and techniques.
• 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.

Required Experience

• 3+ years’ experience in the pharmaceutical, biopharmaceutical industry and/or Supply Chain Management.
• Experience with SAP ERP systems.
• Experience with MyBuy system preferred.

Education

• Associate level of professional education or University degree in the pharmaceutical, biopharmaceutical, or Supply Chain Management, or a master’s degree.
• APICS and/or SCOR certification, or equivalent relevant experience
• PMP/Operational Excellence/Six Sigma/Lean training a plus

Pay Rate & Benefits:

• This is the pay range that Magnit reasonably expects to pay for this position: $53.57 - $71.43/hour on W2.
• Benefits: Medical, Dental, Vision, 401K.

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