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Specialist Direct Material Introduction and Change Coordinator

Roche16 days ago
Mississauga, Ontario
CA$89,256 - CA$117,149/annual
Senior Level
full_time

About the role

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

The Position

  • 12 month contract position with a possible extension to 18 months***

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 Opportunity

  • You will coordinate the execution of direct material-related operational and change management activities for the global Roche manufacturing network
  • You will act as project manager for direct material (DM) introductions, changes, and qualification activities including DM databases, documents, websites, and data repositories
  • You will collaborate with stakeholders to ensure DM-related material assessments, protocols and reports, are delivered in time
  • You will coordinate DM business process, develop process improvements solutions as needed, and guide alignment for the network
  • You will work independently with limited direction and in a team environment with key global customers/stakeholders including: Quality, Process Development, Manufacturing Sciences, Regulatory, and External Suppliers
  • You will identify and manage issues and conflicts in a positive manner
  • You will present at department, cross department, and project team meetings including creating training materials and train stakeholders on DM business processes, tools, and requirements

Qualifications:

  • You will bring a Bachelor's or advanced degree in Life Sciences or related field, with a minimum of 3 years' experience in biotechnology/pharmaceutical manufacturing, process development, or project management
  • You will have strong knowledge of cGMP, quality compliance, bio manufacturing processes, and proficiency in Google applications, quality, and document management systems
  • Experience in change management and/or project management is a must, with strong attention to detail and high-quality output
  • You will have strong interpersonal, organizational, and problem-solving skills, ability to manage multiple tasks and priorities, and work with minimal supervision
  • You will have excellent written and oral communication skills, ability to synthesize information quickly, and work effectively in global, cross-functional teams

Preferred:

  • Experience with Materials in Cell and Gene Therapy is a plus

**Relocation benefits not available for this position**

The expected salary range for this position based on the primary location of Mississauga is 89,256.00 and 117,148.50 of hiring range. Actual pay will be determined based on experience, qualifications, and other job-related factors as determined by the company.

We use artificial intelligence to screen, assess or select applicants for this role.

This posting is for an existing vacancy at Hoffmann-La Roche Ltd.

Who we are

A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.

Let’s build a healthier future, together.

Roche is an Equal Opportunity Employer.

About Roche

Biotechnology Research
10,000+

Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.

Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.

Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. Thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Roche has been recognised as the Group Leader in sustainability within the Pharmaceuticals, Biotechnology & Life Sciences Industry ten years in a row by the Dow Jones Sustainability Indices (DJSI).

For more information, please visit https://careers.roche.com

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