Quality & Compliance Expert at F. Hoffmann-La Roche Ltd - Poland

Zionsville, Indiana, United States -

Full Time

Start Date

Immediate

Expiry Date

11 Feb, 26

Salary

152100.0

Posted On

13 Nov, 25

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Assurance, Regulatory Compliance, Stakeholder Management, Product Management, Risk Management, Lean-Agile Mindset, Data Privacy, Computer Systems Validation, Health Regulatory Frameworks, Quality Standards, IT Systems, Collaboration, Continuous Learning, Business Acumen, Technology Trends, Governance

Industry

Biotechnology Research

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 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. The Opportunity 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. Who you are: 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). Relocation benefits are not 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 California, is between $81,900 and $152,100. 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. This position also qualifies for the benefits detailed at the link provided below. Benefits 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. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.

Responsibilities

You will ensure that Roche’s regulated systems adhere to regulatory standards and manage regulatory risks. Additionally, you will provide oversight for IT systems regarding Computer Systems Validation and escalate non-compliance issues.