Clinical 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

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.

The Clinical Quality Partner is the Quality business partner for CDMA (Clinical Operations) and study teams. This individual is responsible for management of the QMS in support of global clinical study activities including the conduct of combined clinical trials (therapeutic and IVD) under applicable regulations (IVDR, CFR 812, ISO 20916, 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 consistent, high quality clinical evidence generation

• You collaborate with local stakeholders to support the mQMS clinical module to all applicable standards and regulations to ensure the protection of patient safety and rights

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

• You review and approve critical clinical evidence documentation and conduct internal and external audits.

  • Support audit activities (BIMO, NB) and preparedness

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

• You are responsible for building, and then providing effective support for a global team. Doing so in a manner that is consistent with the Roche Values and leadership capabilities. 

• You seek to inspire and lead your clinical project teams 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.

Who You Are

• You have a Bachelor’s and 8+ years of related experience (ideally within a regulated QMS), or 12+ years of related experience (ideally within a regulated QMS)

Preferred Qualifications:

• Experience with quality support for clinical trials

• Specialist knowledge such as: ISO 20916, CFR 812, GCP, GCLP 

• Previous audit support experience

• Strong clinical skills with a background in Clinical Operations

Leadership Knowledge, Skills & Abilities

The Clinical Quality Partner 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 local to Tucson, Indianapolis, Pleasanton, Santa Clara, Branchburg or Carlsbad.  We will consider remote work arrangements under exceptional circumstances.

Relocation benefits are not available for this position.

The expected salary range for this position based on the primary location of Arizona is $101,850 and$189,150.  Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors per