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
At Roche, we thrive to deliver more benefits to our patients as part of our 10-year Pharma vision. An integral part of achieving this vision is to deliver new and innovative data analytics solutions to our scientists across Pharma Technical Operations (PT). PTE is the organization that catalyzes the global development and execution of PT’s Digital and Operational Excellence strategy to enable PT to realize our performance promises. We aim to activate data citizenship and digital mind, revolutionize our FAIR data ecosystem and systems landscape, re-design excellent processes, and generate transformative insights.
As a Validation Lead at Roche PTE, you will play a pivotal role in developing and optimizing the infrastructure that powers our pharmaceutical operations and data insights. This role will develop the validation framework used within the PT organization and ensure compliance and effectiveness for our data and digital solutions.
The Opportunity:
- Develops and drives the overall strategy for validation within the PT organization, working closely with Quality. This includes designing and implementing cutting-edge validation methodologies, frameworks, and tools that positions the company as a leader in the industry.
- Be abreast with the latest regulatory developments and take the lead in collaborating with internal and external Quality bodies / consortia to shape validation approaches through SOPs and guidelines that are co-created with internal Quality and Regulatory functions.
- Ensure execution of validation activities are executed according to comprehensive validation plans and standards for AI models and systems while fostering a culture of continuous improvement by challenging existing validation processes and seeking innovative solutions.
- Ensure data quality and traceability for effective problem identification and root cause analysis. Proactively identify and mitigate potential product risks based on testing insights.
- Conduct benchmarking studies to compare and evaluate our validation processes against industry standards and best practices. Analyze data and trends from leading companies to identify areas for improvement and innovation.
Who you are:
- Bachelor's or Master's degree in Computer Science, Engineering, Statistics, or a related field. 6+ years of experience in Data Science or related fields.
- Deep understanding of AI/ML lifecycle and validation methodologies and experience with Data Products and FAIR principles, ensuring data integrity through ALCOA+ compliance.
- In-depth expertise in CSA (Computer Software Assurance) for lean, compliant, and risk-based validation/testing, coupled with comprehensive knowledge of GxP, CSV, CFR 21 FDA Part 11, Annex 11, and EU AI Act compliance requirements and best practices.
- Strong communication and collaboration skills to effectively convey findings and recommendations to technical and non-technical audiences.
- Broad knowledge in Manufacturing(Clinical or Commercial experience) , or Experience with Supply Chain or Regulatory.
Preferred:
- 2 years experience with data and AI validation in the pharmaceutical or healthcare industry.
Relocation benefits are not available for this posting.
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.
Roche is an Equal Opportunity Employer.
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