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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 Are you ready to shape the future of quality management in healthcare? As an Associate Quality Lead within our Pharma Development Quality (PDQ) function, you will play a vital role in supporting the delivery of quality-focused strategies that reinforce trust in our Quality Management System (QMS). Working with a high degree of independence, you will collaborate with cross-functional teams to ensure our clinical and safety data meets rigorous global regulatory standards. In this dynamic position, you will have the unique opportunity to champion a culture of continuous improvement and innovation. By leveraging data analytics and digital tools, you will help optimize data collection and provide key insights that directly support our mission of delivering life-changing medicines to patients faster and more securely. The Opportunity: Implement Quality Strategies: Support the design, execution, and tracking of risk-based quality management strategies across the PDQ portfolio. Deliver Quality Assurance: Execute targeted activities to assess quality assurance status and generate confidence in our end-to-end systems. Manage Quality Data: Enhance data collection procedures, perform ad-hoc analyses, and deliver high-quality data insights to fulfil external regulatory needs. Present to Health Authorities: Demonstrate the effective implementation of quality strategies. Drive Compliance Projects: Participate in departmental or cross-functional compliance initiatives aimed at optimizing daily operations. Champion Innovation: Drive the adoption of innovative digital tools and technologies into daily workflows to foster a proactive quality culture. Foster Collaboration: Build and maintain an inclusive, supportive work environment while executing departmental goals and initiatives under limited supervision. Audit Execution: Utilize AI and automated tools to execute audits and synthesize audit evidence. Inspection Support: Provide logistical and compliance support for GCP inspections, including scribe duties and back-room document QC. Who You Are You are a proactive, organized professional looking to elevate your career in quality management within a global, life-changing industry. You thrive in environments that value continuous learning, offer room for professional growth, and empower you to work independently to make a genuine impact on patient outcomes. To be successful in this role, you bring: A Bachelor’s degree in a scientific or quality-related discipline, or an equivalent combination of education and 1-3 years' of experience. Experience within the pharmaceutical, biotech, or medical device industry, with a foundational understanding of product development and GxP regulations (e.g., GCP, GVP, MDR). Strong digital and data literacy, with the ability to interpret data and translate it into actionable quality insights. Exceptional organizational and execution skills, alongside a demonstrated ability to take ownership of projects proactively. Developing expertise in Critical to Quality (CtQ) factors and functional group operations. Fluency in written and spoken English, with strong presentation skills. Relocation Benefits are not available for this job posting. #MQRS 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.

What you’ll do

The Associate Quality Lead will support the execution of risk-based quality management strategies and ensure clinical and safety data compliance with global regulatory standards. They will also leverage digital tools to optimize data collection, perform audits, and provide insights to support the delivery of life-changing medicines.

Requirements

Candidates must hold a Bachelor’s degree in a scientific or quality-related discipline with 1-3 years of relevant industry experience. A foundational understanding of GxP regulations and strong data literacy skills are required for this role.

Listed skills

• Quality assurance · Preferred
• Google Cloud · Preferred
• Project management · Preferred

Other relevant skills

Identified from the job description. Confirm important requirements above.

• Quality Management
• Data Analytics
• Regulatory Compliance
• GxP Regulations
• GCP
• GVP
• MDR
• Risk-based Quality Management
• Audit Execution
• Inspection Support
• Data Literacy
• Project Management
• Critical to Quality Factors
• Digital Tools
• Quality Assurance
• Continuous Development
• Quality Culture
• Workflow Management
• Medical Devices
• Quality Management Systems
• Artificial Intelligence
• Data Analysis
• Auditing
• Automation
• Biotechnology
• Continuous Improvement Process
• Creativity
• End Systems
• English Language
• Innovation
• New Product Development
• Operations
• Pharmaceuticals
• Presentations
• Medical Device Reporting

Job areas

• Healthcare
• Science & Research
• Data & Analytics
• Management & Leadership
• Lead Quality Assurance Specialist
• Quality Assurance Specialist
• Product Graders and Testers (except Foods and Beverages)
• Inspectors, Testers, Sorters, Samplers, and Weighers