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 an inclusive workplace. We strive to build teams that represent a range of backgrounds, perspectives, and skills. Embracing inclusion and belonging enables us to create a great place to work and to innovate for patients.

We are seeking a highly motivated Strategic Quality Partner (SQP) to join our Product Development Quality organization, reporting to the Subchapter lead Product Development Quality.  As the Strategic Quality Partner, you will be responsible for ensuring effective partnerships with Development Project Teams in the Molecular Lab - Sequencing Solutions portfolio, thriving for project acceleration and ensuring no delay in milestones and project execution. You drive consistent interpretation & implementation of global requirements across Customer Areas (CAs). You ensure the deployment and implementation of the Design & Development Process and drive awareness and adoption of Risk based decision making across all functions. You are an example of living collective success by working, trusting and empowering each other.

The Opportunity

• Ensure consistent interpretation & implementation of global requirements across Customer Areas (CAs)

• Incorporate lessons learned from all areas of quality across Customer Areas (CA) into project support and ensure PostMarket Quality feedback is built into the requirements

• Ensure development project plans contain the right deliverables according to the Design & Development module to deliver safe and compliant solutions

• Support internal and external audits

• Lead and facilitate constructive discussions e.g. at project team meetings

• Drive awareness and adoption of the Risk Enabler inside and outside of Global Quality & Regulatory decision making; prepare and enable risk-based decisions

• Partner to ensure effective resolution of issues (e.g. CAPA, NC)

• Ensure effective feedback loops and information flow for milestone review.

Who You Are

• Bachelor's degree in science, engineering, business administration or a related field. MBA or advanced degree is considered an advantage.

• 8+ years of experience in the diagnostics industry or a related field in business related Functions

• Strong scientific and technical background preferable in Next Generation Sequencing (NGS) with sound product knowledge, ideally with assay/reagents/system/hardware/software development experience for IVD Products.

• Strong business and financial acumen with an enterprise mindset

• Knowledge of Regulations pertaining to the environment (i.e. ISO 13485, ISO 14971, GDP, GMP, others)

• Excellent communication, presentation, and negotiation skills.

• Strong agile knowledge and capabilities demonstrating new ways of working

• Pragmatic decision making and ability to move forward without a perfect solution

• Demonstrated thorough E2E understanding for lifecycle management

• Strong leadership capabilities, with experience in leading cross-functional teams (Squad Lead, Matrix Lead) and driving change.

Locations

You are located in Santa Clara, California.  This is a primarily onsite role.

Relocation benefits are not available for this position.

The expected salary range for this position based on the primary location of Santa Clara is $119,400 and $255,380.  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.