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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.

As the Technical Transfer Project Leader, you will focus on a quality transfer by ensuring adherence to applicable mQMS requirements and that the processes and procedures are in to efficiently and effectively execute the transfer project.  This role will utilize the expertise in site manufacturing processes to document and communicate to the receiving site, GMP practices.  You will establish partnerships across other organizational groups (Lifecycle, Regulatory, and other business partners) to ensure project success.

The Opportunity

You will be responsible for project risk management, including gaps, bottlenecks/delays & critical path analysis.  

You will implement timeline plans for product availability while ensuring the resolution of technical, scientific and manufacturing related problems.

You will be working cross functionally and collaborate frequently with Manufacturing Operations, Manufacturing Technical Support, Research & Development, Quality Assurance, and the respective Lifecycle teams, to meet all of the deliverables of the project. 

You will be responsible for the identification of sending site hidden factory, completion of gap assessments and implementation of gap closure plans and establishment of new procedures to facilitate the transfer.

You will need to understand and communicate manufacturing best practices at the site and communicate minimum requirements to the core project team to ensure manufacturability and scalability.

You will be the focal point for the Global Operations project and ensure that all Operations stakeholders (Manufacturing, Process Engineering, Validations Engineering, Functional Leads, Quality, Validation, Planning, Procurement, Purchasing and Label Control) needs are understood and communicated through the transfer process.

You will actively use project management techniques to plan, track and ensure timely completion of transfer projects and prepare and deliver presentations of project results to others.

Who You Are

You hold a Bachelor's Degree, preferably in disciplines related to Science, Engineering/Engineering Technology, or Life Science.

You have 8 years relevant work experience in regulated industry.

You have experience operating in a GMP/regulated environment..

You have demonstrated experience with Lean/Continuous Improvement and/or Agile methodologies.

You have strong organizational and problem solving skills along with excellent written and communication skills.

Preferred

You hold a Master’s Degree.

You have 3 years of people leadership.

You are certified in Six Sigma or Green Belt.

You are proficient in Google suite.

Locations

*Relocation benefits are available for this position.

The expected salary range for this position based on the primary location of Arizona is between $85,900 and $159,500.  Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law.  A discretionary annual bonus may be available based on individual and Company performance.  This position also qualifies for the benefits detailed at the link provided below.

Benefits

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.

Ventana Medical Systems, Inc. (Ventana), a member of the Roche Group, innovates and manufactures instruments and reagents that automate tissue processing and slide staining for cancer diagnostics. Our integrated staining, workflow management and digital pathology solutions optimize laboratory efficiency to reduce errors and support diagnosis for pathology professionals. Together with Roche, Ventana is driving personalized healthcare through accelerated drug discovery and companion diagnostics.

Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.

If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.