Quality & Compliance Expert

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 Roches needs.

The Opportunity

You will ensure that Roches regulated / critical systems and services adhere to regulatory standards (e.g. CSV GMP GCP) and regulatory risks are managed adequately to protect Roches 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 everyones responsibility mindset.

Who you are :

You have a minimum of a Bachelors 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 $81900 and $152100. 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 100000 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.

Lets 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 companys 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.

Key Skills

Abinitio,Apprentice,Dermatology,Cost Estimation,Data Networking,Liaison

Employment Type : Full-Time

Experience : years

Vacancy : 1

Monthly Salary Salary : 81900 - 152100