Validation Lead Principal
Validation Lead Principal
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Salary Not Disclosed
1 Vacancy
Job Description
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
At Roche we thrive to deliver more benefits to our patients as part of our 10year 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 of PTs 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 redesign 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 cuttingedge 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 cocreated with internal Quality and Regulatory functions.
Ensure 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:
Bachelors or Masters 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.
Indepth expertise in CSA (Computer Software Assurance) for lean compliant and riskbased 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 nontechnical 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
A healthier future drives us to innovate. Together more than 100000 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 lifechanging healthcare solutions that make a global impact.
Lets build a healthier future together.
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 Roches truly innovative culture.
Roche is an Equal Opportunity Employer.
Employment Type
Full-Time
