Digital Vendor Compliance Lead

F. Hoffmann-La Roche Gruppe; Mississauga; On-site; CAD 85,000 - 120,000; Full time

Job summary

A leading healthcare company is looking for a Digital Compliance Specialist to ensure quality and compliance in digital solutions. The role focuses on vendor assessments, quality assurance, and risk management within Pharma Technical Operations. Candidates should have a Bachelor's degree and at least 5 years of relevant experience in the pharmaceutical or biotechnology sectors.

Qualifications

• 5+ years experience in vendor management or quality assurance roles.
• Certifications in relevant fields like Certified Quality Auditor are desired.
• Strong understanding of digital technology compliance risks.

Responsibilities

• Oversee digital vendor assessments and create remediation plans.
• Develop and monitor vendor KPIs to ensure compliance.
• Conduct risk assessments to identify potential compliance gaps.

Skills

Vendor management

Quality assurance

Risk assessment

Analytical skills

Communication

Education

Bachelor's degree in IT, Computer Science, or Quality Assurance

Advanced degree in Quality Management

Job description

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 the recently formed Global Digital Compliance within the Pharma Technical Operations (PT) Quality organization, we enable the delivery of regulatory-compliant digital solutions with our customers to bring actionable insights and leadership for compliant outcomes for Pharma Technical Operations (PT).

In Digital Compliance, we partner across primary global business functions – PTQ, PT Digital & Operational Excellence (PTE), PT-Development, PT-Regulatory, and PT-Manufacturing, and our partners in Global Informatics. Together, we will build a solid cross-functional and inclusive community, put the power of data into the hands of our people, further develop Lean and Digital skills across PT, and scale up our Digital and Advanced Analytics solutions for the benefit of our colleagues and patients.

The Opportunity:

We seek an individual with excellent knowledge of the pharma data ecosystem, informatics systems, tools, and techniques with a focus on quality and compliance. The successful candidate will play a pivotal role in ensuring the quality and compliance of our digital vendors and business partners.

• You partner with ITQ&S to oversee digital vendor assessments and create remediation plans for compliance.

• You offer quality assurance guidance to high-risk vendors and business partners, ensuring they meet regulatory and company standards.

• You review contract agreements to ensure Roche quality requirements are clearly specified.

• You develop, set, and monitor vendor KPIs to ensure contractual obligations and high performance standards are met.

• You collaborate with the System Owner and BPO to manage quality escalations and identify potential risks, implementing mitigation strategies.

• You conduct risk assessments to identify potential compliance gaps.

Who you are

• You hold a Bachelor's degree in IT, Computer Science, Quality Assurance, or related field, or have extensive comparable work experience; an advanced degree in Quality Management is advantageous.

• You have a minimum of 5 years' experience in vendor management, quality assurance or compliance roles, preferably in the healthcare, pharmaceutical, or biotechnology industry.

• You possess certifications in relevant fields (e.g., Certified Quality Auditor, Certified Vendor Risk Management professional) and regulatory standards (e.g., ISO 9001, ISO 27001).

• You have a strong understanding of IT Quality & Security, digital technology compliance risks, and expertise in developing and monitoring KPIs for vendors.

• You possess in-depth knowledge of quality assurance practices for high-risk vendors and provide expert guidance tailored to regulatory and company requirements.

• You are proficient in identifying, analyzing, and mitigating quality risks, handling quality escalations, and conducting risk assessments to identify potential compliance gaps.

• You exhibit excellent communication, negotiation, analytical, and project management skills to handle multiple initiatives, interact effectively with stakeholders, and develop actionable remediation plans.

Relocation benefits not eligible for this position

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.