Quality & Compliance Expert

About the role

The Position 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.

Responsibilities

• Ensure 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's business.
• Provide automated control insights and streamlined monitoring capabilities, enabling effective and consistent tracking of Information on Quality Oversight.
• Provide independent Quality Assurance oversight/support for IT4IT systems (and some business domains) with regard to Computer Systems Validation and other regulatory systems, including merger and acquisition activities.
• Escalate non-compliance against quality standards to the 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.

Requirements

• You have a minimum of a Bachelor’s degree in Information Technology, Computer Science, Engineering, or equivalent.
• You have a minimum of 5 + 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.
• 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)

Qualifications

• You are passionate about major technology trends and continuously learning new capabilities (e.g. AI, Cloud, Data Meshes).

Skills

• Lean-Agile Mindset
• Product Management Practices
• Quality & Regulatory Expertise
• Health Regulatory Frameworks
• Risk and Control Frameworks

Benefits

Relocation benefits are available for this job posting. Must be willing to work onsite in our Indianapolis, Roche location. The expected salary range for this position, based on the primary location of Indianapolis, is between $82,000 and $117,200. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance.

Details of the benefits