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At Roche, we are passionate about transforming patients’ lives, and we are bold in both decision and action - we believe that good business means a better world. That is why we come to work every single day. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow. Roche is strongly committed to a diverse and inclusive workplace. We strive to build teams that represent a range of backgrounds, perspectives, and skills. Embracing diversity enables us to create a great place to work and to innovate for patients.

As a Clinical Laboratory Quality Lead, you are the site Quality lead for the CLIA/CAP accredited laboratory (may also include ISO 15189, NY state, and other local requirements and regulations depending on the geographic location of the laboratory and business need). You are  responsible for management of the QMS in support of all laboratory activities including the conduct of combined clinical trials (therapeutic and IVD) under applicable regulations (IVDR, CFR 812, ISO 20916, ICH E6 (R2) and others as required depending on the geographic location of the trial and lab).

The Opportunity: 

You collaborate across the chapter, function, division, and enterprise on Roche global initiatives for the consistent delivery of high quality laboratory services. 

You collaborate with local stakeholders to implement laboratory QMS to all applicable standards and regulations to ensure the protection of patient safety and rights.

You communicate and collaborate with leadership regarding laboratory Quality and QMS

You provide guidance and expertise on GCP including ISO 20916, IVDR, CFR 812, and other relevant clinical study regulations and standards

You manage local Quality activities including:

External and Pharma audit lead

Management Review and Quality metrics

Quality Improvements and initiatives

Development of training materials on quality and regulatory topics and standards

Who You Are:

You have a Bachelors in Science or a Related Field

You have a minimum 7 years experience with a regulated QMS

You hold specialist knowledge in: CLIA, CAP, ISO 15189, NY state clinical laboratory regulations, ISO 20916, CFR 812, GCP, GCLP

Leadership Skills:

You are also responsible for building, and then providing effective matrix-leadership for a global team. Doing so in a manner that is consistent with the Roche Values and leadership capabilities. You will seek to inspire and lead your local laboratory team to create transformative solutions, and to influence their prioritization and uptake in the wider organization, in order to ensure that customer solutions are at the forefront of Roche and deliver its optimal contribution to the Roche Diagnostics Vision.

The Clinical Laboratory Quality Lead is expected to demonstrate the Roche Operating Principles and contribute to the Roche Group. The Roche Operating Principles are: 

Put patients first

Follow the science

Act as one team

Embrace differences

Accelerate learning

Simplify radically

Make impact now

Think long term

Locations:

You are based in Tucson Arizona. 

Relocation benefits are not available for this opportunity.

Up to 10% travel, as needed.

The expected salary range for this position based on the primary location of Arizona is $98,900 to $183,700.  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

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Ventana Medical Systems, Inc. (Ventana), a member of the Roche Group, innovates and manufactures instruments and reagents that automate tissue processing and slide staining for cancer diagnostics. Our integrated staining, workflow management and digital pathology solutions optimize laboratory efficiency to reduce errors and support diagnosis for pathology professionals. Together with Roche, Ventana is driving personalized healthcare through accelerated drug discovery and companion diagnostics.

Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.

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.