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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 team within the Pharma Technical Operations (PT) Quality organization, we enable the delivery of GMP-compliant digital solutions to our customers, providing actionable insights and leadership for compliant outcomes in Pharma Technical Operations (PT).
In Digital Compliance, we partner across primary global business functions, including PTQ, PT Digital & Operational Excellence (PTE), PT Development, PT Regulatory, and PT Manufacturing, as well as our partners at Roche Digital Technology (formerly 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.
Do you bring experience in implementing or enabling the GxP Qualification of Digital Vendors in the pharma or diagnostic industry, and are you looking for an impactful role? We seek an individual with excellent knowledge of the pharma GxP data and digital ecosystem, informatics systems and platforms, and digital tools, with a focus on quality and compliance.
The Opportunity:
We seek an dynamic and experienced GxP Digital Vendor Compliance Lead to join our team. The successful candidate will play a pivotal role in ensuring the quality and compliance of our digital vendors and business partners. This position requires strong analytical skills, attention to detail, and the ability to manage and mitigate risks effectively.
* You partner with IT Quality & Security (ITQ&S) to oversee digital vendor assessments and develop remediation plans to ensure compliance with company standards
* You provide expert quality assurance guidance for high-risk vendors and business partners, ensuring adherence to regulatory and company requirements
* You review contractual agreements to ensure Roche quality requirements are clearly defined and outlined
* You develop, set, and monitor vendor key performance indicators (KPIs) to ensure contractual performance standards are consistently met
* You collaborate with System Owners and Business Process Owners (BPOs) to manage quality escalations and implement risk mitigation strategies
* You conduct risk assessments to identify and address potential compliance gaps with vendors and business partners
* You ensure digital vendors and business partners comply with both regulatory frameworks and Roche policies
Who You Are
* You hold a Bachelor’s degree (or equivalent experience) in IT, Computer Science, Quality Assurance, or a related field, with at least 5 years of experience in digital/IT vendor management, quality assurance, or compliance roles
* You have proven expertise in performing vendor assessments, developing remediation plans, and working within the healthcare, pharmaceutical, or biotechnology industries
* You bring knowledge and/or certification in relevant regulatory standards (e.g., ISO 9001, ISO 27001) and fields (e.g., Certified Quality Auditor)
* You possess strong IT Quality & Security expertise, including skills in developing and monitoring vendor KPIs and interpreting compliance within contractual agreements
* You demonstrate in-depth quality assurance knowledge, particularly for managing high-risk vendors, and provide expert guidance tailored to requirements
* You excel in risk management, identifying and mitigating quality risks, handling escalations, and collaborating with stakeholders on digital vendor relationships
* You have excellent analytical, communication, and project management skills to assess vendor performance, resolve compliance issues, and manage initiatives effectively
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.
Seniority level
* Seniority level
Associate
Employment type
* Employment type
Full-time
Job function
* Job function
Quality Assurance
* Industries
Pharmaceutical Manufacturing, Biotechnology Research, and Medical Equipment Manufacturing
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