Regulatory Innovation & Sustainment Professional - Quality & Compliance

Job summary

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 A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the he…

Job details

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 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 a Regulatory Innovation & Sustainment Professional within Pharma Development Regulatory's (PDR) Quality & Compliance capability, you will be accountable for creating and maintaining PDR’s Quality Management System (QMS) framework. This includes fostering innovation, identifying and implementing continuous improvement opportunities and developing risk-based quality strategies. The Opportunity Act as a trusted partner to senior business stakeholders, leading or supporting cross-functional collaboration to ensure global quality standards are met while navigating complex regulatory landscapes. Collaborate with global teams to mature and sustain PDR’s Quality & Compliance capabilities. Monitor external trends and regulatory changes to ensure ongoing readiness. Identify opportunities for continuous improvement and drive strategic change initiatives. Lead internal/external audits, Health Authority inspections, and risk assessments. Ensure compliance with global regulatory standards including Good Clinical Practice / Good Pharmacovigilance Practice (GCP/GVP) and Medical Device related requirements, where applicable. Optimize processes to enable operational excellence and maintain our license to operate. Who You Are You have a Bachelor’s degree or equivalent in a scientific or quality-related field (an advanced degree is preferred). You have a minimum of 7 years of experience in Quality & Compliance, Regulatory Affairs or Drug and/or Device Development, with a strong understanding of regulated environments, industry frameworks, data and digital systems. You’re a strategic thinker and problem solver who thrives in a fast-paced, collaborative environment, driven by purpose, excited by innovation, and confident in influencing change across a complex organization. You are skilled at analyzing complex quality data and translating these insights into clear, actionable executive reporting and strategic messages. You possess exceptional verbal and written communication skills with proven ability to communicate and collaborate effectively across global/local matrixed teams and senior leadership. You possess a continuous improvement mindset and a proactive approach to solving challenges, with the ability to assess end-to-end processes, identify inconsistencies, and improve process effectiveness and efficiency. You can influence best practice adoption. Preferred Experience with audits or inspections is a plus, but not essential. **Relocation benefits are not available for this position.** The expected salary range for this position based on the primary location of Mississauga is 136,936.00 and 179,728.50 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. We believe it’s urgent to deliver medical solutions right now – even as we develop innovations for the future. We are passionate about transforming patients’ lives. We are courageous in both decision and action. And we believe that good business means a better world. That is why we come to work each day. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow. We are proud of who we are, what we do, and how we do it. We are many, working as one across functions, across companies, and across the world. We are Roche.

What you’ll do

The professional is accountable for creating and maintaining the Quality Management System framework within Pharma Development Regulatory. This involves leading audits, monitoring regulatory trends, and driving strategic change initiatives to ensure global quality standards are met.

Requirements

Candidates must have a bachelor's degree in a scientific or quality-related field and at least 7 years of experience in Quality & Compliance or Regulatory Affairs. Strong skills in strategic thinking, complex data analysis, and global stakeholder communication are required.

Listed skills

• Continuous Improvement · Preferred
• collaborative · Preferred
• analysis · Preferred
• Collaboration · Preferred
• Teams · Preferred
• Compliance · Preferred
• management · Preferred
• Communication · Preferred
• Development · Preferred
• future · Preferred
• Communication Skills · Preferred
• Cross-Functional Collaboration · Preferred

Other relevant skills

Identified from the job description. Confirm important requirements above.

• Quality Management System
• Regulatory Compliance
• Risk-Based Quality Strategies
• Continuous Improvement
• Internal and External Auditing
• GCP
• GVP
• Medical Device Requirements
• Stakeholder Management
• Strategic Thinking
• Data Analysis
• Executive Reporting
• Cross-functional Collaboration
• Process Optimization
• Regulatory Affairs
• Drug and Device Development

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