Job 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

A healthier future. Its what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. Thats what makes us Roche.

Quality is a competitive advantage for Roche. It allows us to deliver highquality products to patients, ensures our right to operate, and helps us create value through process excellence and continual improvement efforts. Quality is every patients right and every employees responsibility.

As a RIS Senior Quality Partner, you are accountable for ensuring your contributions are delivered in a way that lives up to our commitments to each other and the We@Roche Diagnostic Commitments. You are responsible for building and developing your capabilities to contribute more to the team, customers and patients. You apply new approaches to improving your work to increase productivity, reduce costs or mitigate significant compliance issues within your area of influence. You work as a strategic business partner to help break down silos between organizations (internal and external) all which lead to developing and producing safe, quality products and services that meet customer requirements throughout the entire lifecycle. You push the boundaries to enable and implement smart, riskbased compliant processes that result in quick and efficient innovation.

Your Opportunity

• You drive business results and customer value by performing activities as required to meet Q&R goals and objectives independently.
• You are able to identify improvements and implement through collaboration with your manager.
• You act as a coach for colleagues with less experience and help them develop skills/expertise.
• You document authoring and review as required to support changes and perform technical reviews, as applicable. This may require collaboration with supervisor on technically complex technical reviews.
• You prepare documentation for and participate in audits as applicable. You are able to troubleshoot issues as they arise, develop and independently implement solutions to ensure that daily work is completed without jeopardizing compliance. You communicate significant quality or regulatory issues and risks that may impact product quality or regulatory compliance in a timely manner to Executive Management.
• You advance the work of the Networks, making tradeoffs and breaking silos . You initiate activities independently and initiate interactions across departments as applicable.
• Empower and enable the Networks by maintaining strong partnerships with colleagues and business partners to assure alignment around strategic projects and daytoday activities. You build a culture of continuous improvement.
• You enable the organizations New Ways of Working and act as rolemodel for Agile Leadership behaviors, as well as for our culture, mindset & behaviors as defined in Diagnostics Operating Principles.

Who You Are

• You have a Bachelors or Master degree in Life Science, Data Science or related subject, or equivalent experience.
• You have 3 - 5 years of experience and are recognized as an expert in your own job discipline.
• You have worked in more than one function within quality management and may have worked outside of quality management. You can manage highly complex and/or global projects, or equivalent experience.

Preferred Qualifications

The following skills and experience are strongly preferred for this role:

• Exposure to and experience working in a software development environment; familiarity with IEC 62304 and 82304 standards for software, the Scaled Agile Framework (SAFe), and Agile ways of working.
• Exposure to and experience working with cybersecurity and privacy processes and principles; familiarity with the ISO 27001 family of standards and FDA cybersecurity guidance documents.
• Exposure to or familiarity with software development principles for AI/ML derived medical devices.

Locations

You are based in Santa Clara or Indianapolis.

*Relocation Assistance is not available for this opportunity.*

The expected salary range for this position based on the primary location of Santa Clara, California is $95,060 and $176,500. Actual pay will be determined based on experience, qualifications, geographic location, and other jobrelated 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

Benefits information.

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 lifechanging 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 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.

Job Tags

Similar Jobs