Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.

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 an  IT Risk and Audit Specialist - Compliance Lead, you will join our diverse Informatics community of smart, fun, wholehearted, and engaged professionals from various functional areas. You will share our community values of passion, courage, integrity, and gratitude -- all in service of our mission, “doing now what patients need next.”

Your primary accountability is to provide leadership and expert guidance in ensuring that our products and systems are in compliance with applicable regulations, operating securely, and that risks are being managed prudently. You will be responsible for system risk assessments, evaluating cyber resiliency and compliance with internal and external requirements. Support of the ongoing development, implementation and management of compliance procedures and controls in order to maintain the confidentiality, integrity, and availability of critical information assets. By being deeply engaged with our stakeholders ranging from business partners, legal, procurement, and quality professionals, you will develop a strong understanding of safety, clinical and medical data and build a strong framework to assess the quality and security of our systems; professionally you bring a strong competency in design, creation, and adoption of novel validation and line of control strategies, ensuring data integrity, security, and privacy to teams across the product development lifecycle - including projects deployed in the Clinical & Medical device space. You are self motivated and have the ability to engage your agile squad to bring impact to the business value stream. As a Compliance Lead, you will establish strong relationships and manage stakeholders across the globe. You are someone who can negotiate and influence at all levels.

The Opportunity:

You will collaborate with internal teams and external partners on global projects to understand needs, ensure alignment, and address interdependencies.

You will  foster collaboration and effective communication to resolve issues throughout the project lifecycle.

You will analyze legal agreements and regulations to ensure compliance and provide guidance for decision-making and strategic initiatives.

You will oversee system conformance ensuring systems meet user needs, regulatory requirements, and classify GxP systems.

You will safeguard critical data in compliance with GDPR, HIPAA, PIPEDA and other laws, guiding teams on maintaining compliance.

You will oversee compliance documentation processes, including risk assessments and privacy impact assessments, for IT and business partners.

You will have regulatory expertise to maintain in-depth knowledge of global health authority regulations and collaborate with privacy, IT security, and quality teams to ensure compliance.

Who you are 

You will bring a BA/BS in life science, informatics, business, or equivalent; MA/MS and postgraduate coursework desirable.

3 - 5 years of experience with domain knowledge in the pharmaceutical industry, manufacturing, quality assurance, and computer systems validation.

You will have practical knowledge of 21 CFR part 11, EMA Annex 11, HIPAA, SaMD, and ISO 13485.

You will bring experience in program or IT project management and familiarity with Software Development Life Cycle methodologies, including Agile.

You will have a strong understanding of risk management principles and methodologies.

You will bring previous experience leading cross-functional teams, providing innovative solutions, and making decisions with cross-functional impact.

Strong executive-level communication skills, relationship building, problem-solving abilities, proficiency with collaboration tools (e.g., Git, Jira, Trello, Google CSuite), and a proven track record in adopting innovative techniques.

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Relocation benefits not eligible for this position 

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

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 Roche's truly innovative culture.

Roche is an Equal Opportunity Employer.