Quality & Compliance Expert

Roche; Mississauga; On-site; CAD 80,000 - 100,000; Full time

Job summary

A leading global healthcare company in Mississauga is seeking a skilled Quality Assurance Specialist to ensure compliance with regulatory standards and enhance the quality of IT systems. You will collaborate with stakeholders to manage product lifecycles and drive quality initiatives. Candidates should have a Bachelor's degree in a relevant field and at least 7 years of experience. This full-time position offers an opportunity to make a significant impact in healthcare.

Qualifications

• Minimum of 7 years of experience in information technology, data science, quality or related fields.
• Exhibits a Lean-Agile Mindset and excels at Product Management practices.
• Understands health regulatory frameworks (FDA, EMEA, ISO9001, ISO13485, PIC/s).

Responsibilities

• Ensure adherence to regulatory standards for Roche's systems.
• Participate in developing new standards related to Computer Systems Validation (CSV).
• Connect with stakeholders to understand compliance needs and shape product direction.

Skills

Abinitio

Data Networking

Liaison

Education

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

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.

The Position

A healthier future. Thats 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, ensuring a culture where quality is everyone\'s responsibility.

Who you are

• A minimum of Bachelors 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 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 life-changing healthcare solutions that make a global impact.

Lets build a healthier future together.

Roche is an Equal Opportunity Employer.

Key Skills

Abinitio, Apprenticeship, Dermatology, Cost Estimation, Data Networking, Liaison

Employment Type : Full-Time

Experience : years

Vacancy : 1