Global Clinical Materials Manager

Global Clinical Materials Manager

South San Francisco, CA

Duration: 12 Months

Work Environment: Majority in-office (49% Home Office allowed)

Department: PTDS-Global Competency Center Production Enablement

Reports to: Head, Global Clinical Materials Management

Location: South San Francisco (SSF)

Role Summary:

The Global Clinical Materials Manager (GCMM) ensures seamless, on-time production of drug products and packaging materials for Roche’s clinical trials. The GCMM is responsible for the procurement and management of clinical materials, ensuring their availability and compliance with international standards and regulations.

Required Experience:

• 3 years in pharmaceutical, biopharmaceutical, or Supply Chain Management industry.
• Experience with SAP ERP systems; familiarity with MyBuy system is preferred.

Education & Certifications:

• Required: Associate degree or University degree in Pharmaceutical/Biopharmaceutical Sciences, Supply Chain Management, or related field.
• Preferred: APICS/SCOR certification or equivalent experience.
• Additional Certifications (Preferred): PMP, Six Sigma, Lean, or Operational Excellence training.

Key Responsibilities:

Primary Responsibilities:

• Master Data Management:
• Maintain accurate master data for drug products and packaging materials.
• Compile product-specific documents and define/update master data in SAP systems.
• Procurement Management:
• Manage purchase orders for drug products (Roche and external) and packaging materials in the procurement system.
• Coordinate with suppliers for drug products and packaging material, ensuring KPI transparency and continuous improvement.
• Support warehouse in goods receipt questions and perform virtual goods receipts.
• Batch Availability & QA Compliance:
• Ensure availability of drug product and packaging materials for manufacturing.
• Compile GMP- and customs-compliant goods receipt dossiers for QA release of drug products and packaging materials.
• Ensure on-time QA-release or AFM (Authorization for Further Manufacturing) of materials.
• Manage shelf-life extensions for drug products and packaging materials at batch level.
• Financial and Issue Management:
• Confirm received quantities for accurate cost charging in financial systems.
• Lead issue management regarding procurement and goods receipt of drug products and materials.
• Continuous Improvement & Performance Monitoring:
• Actively monitor KPIs for team and vendor performance.
• Lead and participate in global and local process optimization projects.
• Collaborate with Business Process Managers for continuous improvement and process resolution.
• System Improvements & Documentation:
• Support SAP system improvements (SAP CLARA P96).
• Create and update SOPs, department documents, and training materials.

Job Requirements:

Competencies:

• Pharma Supply Chain Expertise: Solid understanding of pharmaceutical supply chain and clinical packaging processes.
• Cultural Awareness & Communication: Ability to work with diverse cultures and teams, excellent verbal and written communication skills in English (German is a plus).
• Problem-Solving & Decision Making: Strong analytical skills and attention to detail.
• Project Management & Independency: Ability to lead projects and work independently, managing priorities and deadlines.
• Process Improvement & Continuous Learning: Strong focus on optimization and quick learning across different domains.
• GMP Compliance & Documentation: Deep knowledge of GMP environments and regulatory documentation.
• Customer-Focused & Trustful Relations: Ability to build strong, trusting relationships with business partners.