Global Clinical Materials Manager

Roche

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Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.

The Position

A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. 

That’s what makes us Roche.

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 Opportunity:

  • As the single point of contact you will ensure the availability of drug products and packaging materials for clinical manufacturing.
  • You will be accountable for Master Data Management by maintaining accurate master data for drug products and packaging materials, including compiling and updating product-specific data and documents in SAP systems.
  • You will lead all aspects of procurement by planning for and managing purchase orders for various drug products and packaging materials from both internal and external suppliers using the appropriate procurement system.
  • Supplier Relationship Management will include managing and evaluating suppliers’ performance, ensuring transparency through KPIs, and implementing continuous improvements.
  • You will oversee Quality Assurance and Compliance by ensuring batch availability and compile GMP- and customs-compliant dossiers for QA release, handle virtual goods receipts, and manage shelf-life extensions and associated documentation.
  • You will oversee issue management in global clinical supply, support inspections, and engage in GMP deviation and change management to drive continual improvement.
  • You will lead and participate in projects to optimize processes, collaborate with Business Process Managers, support system enhancements, and create/update SOPs and training documents.

Who you are 

  • You will have an Associate-level or University degree in pharmaceutical, biopharmaceutical, or supply chain management with 3+ years of experience in pharma supply chain and clinical packaging processes.
  • You will be proficient in supply chain/business processes, Good Manufacturing Processes (cGMP) theories, principles, and techniques and able to adhere to GMP procedures and standards.
  • You will be capable of managing projects from initiation to delivery, working independently, setting priorities, and being adaptable
  • High cultural awareness and social competence for effective cooperation and communication across diverse cultures and countries.
  • Strong teamwork, collaboration, negotiation, problem-solving, and decision-making skills, with high attention to detail and understanding of systems and technical designs

Preferred:

  • APICS and/or SCOR certification
  • PMP/Operational Excellence/Six Sigma/Lean training a plus.

Relocation benefits not eligible for this position 

Who we are

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Roche Pharma Canada has its office in Mississauga, Ontario and employs over 850 employees. The Mississauga facility is bright, vibrant, fosters collaboration and teamwork, and is reflective of Roche’s truly innovative culture.

As of January 4, 2022, Roche requires all new employees who work in Canada to be fully vaccinated against COVID-19 on the date they take office. This requirement is a condition of employment at Roche that applies regardless of whether the position is on a Roche campus or remotely. If you have a valid reason for not being fully immunized, which is limited to certain specific medical reasons or other valid reasons protected by applicable human rights laws, you may request an exemption and / or adaptation measures regarding this vaccination requirement.

Roche is an Equal Opportunity Employer.

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Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.

The Position

A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. 

That’s what makes us Roche.

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 Opportunity:

  • As the single point of contact you will ensure the availability of drug products and packaging materials for clinical manufacturing.
  • You will be accountable for Master Data Management by maintaining accurate master data for drug products and packaging materials, including compiling and updating product-specific data and documents in SAP systems.
  • You will lead all aspects of procurement by planning for and managing purchase orders for various drug products and packaging materials from both internal and external suppliers using the appropriate procurement system.
  • Supplier Relationship Management will include managing and evaluating suppliers’ performance, ensuring transparency through KPIs, and implementing continuous improvements.
  • You will oversee Quality Assurance and Compliance by ensuring batch availability and compile GMP- and customs-compliant dossiers for QA release, handle virtual goods receipts, and manage shelf-life extensions and associated documentation.
  • You will oversee issue management in global clinical supply, support inspections, and engage in GMP deviation and change management to drive continual improvement.
  • You will lead and participate in projects to optimize processes, collaborate with Business Process Managers, support system enhancements, and create/update SOPs and training documents.

Who you are 

  • You will have an Associate-level or University degree in pharmaceutical, biopharmaceutical, or supply chain management with 3+ years of experience in pharma supply chain and clinical packaging processes.
  • You will be proficient in supply chain/business processes, Good Manufacturing Processes (cGMP) theories, principles, and techniques and able to adhere to GMP procedures and standards.
  • You will be capable of managing projects from initiation to delivery, working independently, setting priorities, and being adaptable
  • High cultural awareness and social competence for effective cooperation and communication across diverse cultures and countries.
  • Strong teamwork, collaboration, negotiation, problem-solving, and decision-making skills, with high attention to detail and understanding of systems and technical designs

Preferred:

  • APICS and/or SCOR certification
  • PMP/Operational Excellence/Six Sigma/Lean training a plus.

Relocation benefits not eligible for this position 

Who we are

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Roche Pharma Canada has its office in Mississauga, Ontario and employs over 850 employees. The Mississauga facility is bright, vibrant, fosters collaboration and teamwork, and is reflective of Roche’s truly innovative culture.

As of January 4, 2022, Roche requires all new employees who work in Canada to be fully vaccinated against COVID-19 on the date they take office. This requirement is a condition of employment at Roche that applies regardless of whether the position is on a Roche campus or remotely. If you have a valid reason for not being fully immunized, which is limited to certain specific medical reasons or other valid reasons protected by applicable human rights laws, you may request an exemption and / or adaptation measures regarding this vaccination requirement.

Roche is an Equal Opportunity Employer.

Read Full Description

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