Quality & Compliance Expert

Roche; Winnipeg; On-site; CAD 60,000 - 80,000; Full time

Job summary

A global healthcare company seeks a Quality Assurance professional in Winnipeg. You will ensure Roche's regulated systems adhere to standards and manage product lifecycles, collaborating with various stakeholders. Ideal candidates have a degree in IT and 7+ years in relevant fields, showcasing regulatory expertise. Join our mission for a healthier future.

Qualifications

• 7+ years of experience in information technology, data science, or quality.
• Executive presence and strong business acumen.
• Keen understanding of health regulatory frameworks.

Responsibilities

• Ensure Roche’s systems meet regulatory standards.
• Manage product service levels and governance.
• Facilitate quality discussions for solutions.

Skills

Information Technology

Data Science

Quality Assurance

Lean-Agile Mindset

Risk Management

Education

Bachelor’s degree in Information Technology, Computer Science, Engineering or equivalent

Tools

Regulatory Frameworks (e.g., FDA, ISO9001)

Data privacy laws (e.g., HIPAA, GDPR)

Job description

Overview

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.

A healthier future. That’s what drives us.

Our ambition is to empower Integrated Informatics to deliver quality and compliance in an efficient way, right the first time.

As part of the Quality Assurance team, you will be a trusted partner for customers to ensure and improve the overall quality of IT systems throughout their lifecycle. You are a customer-focused, highly collaborative individual who will work with delivery units across both Business and Informatics to advance existing and emerging business critical technology according to Roche’s needs.

The Opportunity

You will assure that Roche’s regulated/critical systems and services adhere to regulatory standards (e.g. CSV, GMP, GCP) and regulatory risks are managed adequately to protect Roche business. By providing automated control insights and streamlined monitoring capabilities, an effective and consistent tracking of Information on Quality Oversight is enabled. Governance and processes are provided to comply with GxP, Data privacy laws and regulations when processing and hosting Roche data.

• Participate in the development of new standards and revision of existing standards related to Computer Systems Validation (CSV).
• Assemble global feedback on proposed or existing standards and tools and provide recommendations for new guidance/standards or revisions to existing guidance/standards.
• Provide independent Quality Assurance oversight/support for IT4IT systems (and some business domains) with regard to Computer Systems Validation and other regulatory systems.
• Escalate non-compliance against quality standards to appropriate governance bodies and Risk Management functions for resolution.

Stakeholder Management and Partnering

• Connect and understand the regulatory and compliance needs in the context of the stakeholders and closely partner with them to develop the strategic direction of the product. Shape the Digitalized Compliance roadmap and portfolio to deliver high value outcomes for the customers of the product.
• Define and deliver the product roadmap and manage the end-to-end product lifecycle (including continuously facilitating product discovery), ensuring it delivers tangible and meaningful value aligned with customer needs and expected business outcomes.

Impact and Complexity

• Define and manage product service levels, governance and operational support model aligned with stakeholder needs
• Lead or coordinate quality and compliance discussions for pragmatic solutions assuring a quality is everyone’s responsibility mindset

Who you are

• A minimum of Bachelor’s degree in Information Technology, Computer Science, Engineering or equivalent.
• A minimum of 7+ years of experience in information technology, data science, quality or related professional competence
• Exhibits a Lean-Agile Mindset and excels at Product Management practices
• Takes 'progressive risk'--not thrill-seeking, but risk that leads to opportunity
• Has a keen Quality & Regulatory Expertise: You are passionate about major technology trends and continuously learning new capabilities (e.g. AI, Cloud, Data Meshes)
• Demonstrates an executive presence, strong business acumen, ability to navigate ambiguity, and manages complexity
• Understanding of health regulatory frameworks (FDA, EMEA, ISO9001, ISO13485, PIC/s)
• Understanding of risk and control frameworks and quality standards including government guidelines and laws (NIST, HIPAA, GDPR, EU AI Act)

Relocation benefits are not available for this job posting.

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.