Principal Quality Partner

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. It’s 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. That’s what makes us Roche.
 

As an Operations Quality Principal Quality Partner in the Planning and Measurement team 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, risk-based compliant processes that result in quick and efficient innovation.

Your Opportunity

• You coordinate, execute and lead Management Review and Monthly Execution and Product Monitoring, ensuring the organization understand the risks and that we have action to ensure continuous control of our processes, maintaining our right to operate.

• Based on your Quality System plan, you lead the external audits, ensuring we meet our obligation under the health authorities and regulatory agencies.  You communicate with authorities and stakeholders to prepare, lead and follow up on external inspections.

• As a QMS Launch Manager, you are responsible for successful implementation and execution of the mQMS at your sites.

• You work closely with the Management Representative and Executive Leadership, understanding the strategy at the site to ensure effectiveness of the Quality Management System.

• You are responsible for training, coaching,  mentoring and leading other quality managers or business partners, as applicable in a professional manner to ensure that business needs are being met.  You have a deep product and process understanding and are able to translate this understanding into tangible learnings for other employees. 

•  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 Network, making tradeoffs and breaking silos. You initiate activities independently and initiate interactions across departments as applicable. 

• Empower and enable the Network by maintaining strong partnerships with colleagues and business partners to assure alignment around strategic projects and day-to-day activities. You build a culture of continuous improvement.

• You are able to identify improvements and implement independently, while participating in cross functional Global initiatives.

• You enable the organization’s New Ways of Working and act as role-model for Agile Leadership behaviors, as well as for our culture, mindset & behaviors as defined in Diagnostics Operating Principles.

Who You Are

• You have a Bachelor’s or Master degree in Life Science, Data Science or related subject, or equivalent experience. 

• You have 5-10 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.

Locations:

You are based in Indianapolis, Indiana.

*No relocation assistance is available for this opportunity.*

The expected salary range for this position based on the primary