Quality & Compliance Expert

Roche • Indianapolis, IN

4d • $82,000 - $117,200 • Onsite

About 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. You will 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. 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 the 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, 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. 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 assuring a quality is everyone’s responsibility mindset.

Requirements

• Minimum of a Bachelor’s degree in Information Technology, Computer Science, Engineering, or equivalent.
• 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.
• 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).
• Must be willing to work onsite in our Indianapolis, Roche location.

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 for effective and consistent tracking of Information on Quality Oversight.
• Provide governance and processes to comply with GxP, Data privacy laws, and regulations when processing and hosting Roche data.
• Participate in the development of new standards and the 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, including merger and acquisition activities.
• Escalate non-compliance against quality standards to the appropriate governance bodies and Risk Management functions for resolution.
• 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.
• 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 assuring a quality is everyone’s responsibility mindset.

Benefits

• Relocation benefits are available for this job posting.
• A discretionary annual bonus may be available based on individual and Company performance.
• This position also qualifies for the benefits detailed at the link provided below.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior