Roche · 2 hours ago
Quality & Compliance Expert
Indianapolis, IN
Full-time
Onsite
Mid, Senior Level
$101K/yr - $188K/yr
7+ years expRoche is a global healthcare company dedicated to advancing science and ensuring access to healthcare. The Quality & Compliance Expert will ensure that Roche's regulated systems adhere to regulatory standards and provide oversight for IT systems, collaborating with stakeholders to develop strategic compliance initiatives.
BiotechnologyHealth CareHealth DiagnosticsOncologyPharmaceuticalPrecision Medicine
Responsibilities
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
Qualification
Required
You have a minimum of a Bachelor's degree in Information Technology, Computer Science, Engineering, or equivalent
You have a minimum of 7 + 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
Has a keen Quality & Regulatory Expertise: You are 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)
Benefits
Relocation benefits are available for this job posting.
A discretionary annual bonus may be available based on individual and Company performance.
Company
Roche
Roche is a pharmaceutical and diagnostics company that offers medicines and diagnostic tests for various medical conditions and diseases.
10001+ employees
H1B Sponsorship
Roche has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (12)
2024 (9)
2023 (6)
2022 (2)
2021 (2)
Funding
Current Stage
Public CompanyTotal Funding
$7.79BKey Investors
SoftBankSCALE AINovartis
2021-08-04Post Ipo Equity· $5B
2020-12-07IPO
2020-05-06Post Ipo Equity· $0.5M
Leadership Team
Alan Hippe
Member of the Executive Board - Group CFO
Christine Bakan
Global Head and Group Vice President, Computational Science and Informatics R&D
Recent News
2026-01-25
2026-01-23
2026-01-22
Company data provided by crunchbase