Strategic Quality Partner

Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people's varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.

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.

We are seeking a highly motivated Strategic Quality Partner (SQP) to join our Product Development Quality organization, reporting to the Subchapter lead Pre-Market Development Quality. As SQP, you will be responsible for ensuring effective partnerships with Development Project Teams, 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 D&D module and drive awareness and adoption of the Risk Enabler inside and outside of Global Q&R decision making.

The Opportunity

• You act as a single point of contact within project teams (New Product Development / Product Change) and partner with Design Quality Partners (DQP) to decide efficient and effective documentation of milestone deliverables. You are skilled in leading strategic topics and decisions. You facilitate constructive discussions e.g. at project team meetings.

• You partner with internal and external stakeholders across the value chain to incorporate learnings in the development process. You ensure effective feedback loops and information flow for milestone review. This includes developing and enhancing playbooks to optimize/accelerate/enhance Pre Market Quality contributions for a given type of project/technology.

• You ensure consistent interpretation & implementation of global requirements across Customer Areas (CAs) and 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.

• You ensure development project plans contain the right deliverables according to D&D module to deliver safe and compliant solutions.

• You support internal and external audits and partner to ensure effective resolution of issues (e.g. CAPA, NC).

• You drive awareness and adoption of the Risk Enabler inside and outside of Global Q&R decision making; prepare and enable risk based decisions.

• You advance the work of the organization by continuously improving knowledge management within Pre Market Quality, fostering the effective sharing and retention of valuable knowledge and expertise.

• You ensure effective change management in Product Development Quality, R&D and other functions, while fostering a culture of innovation and continuous improvement, nurturing a creative and problem-solving mindset throughout R&D, Product Development Quality and other functions.

Who You Are

• You have a Bachelor's degree in chemical, biological, computer science, or a related field. MS or advanced degree is considered an advantage.

• You have + 8 years of experience in the healthcare diagnostics industry or a related field in product development related functions. The ideal candidate has experience working on product development projects that involve computational aspects (ML, AI, SaMD, etc.) and chemical/biological aspects, whether combined or separate.

• The successful applicant should be able to demonstrate a deep understanding of the product development process within a regulated environment for products that are either computational and chemical/biological in nature.

• You have strong business and financial acumen with an enterprise mindset with scientific and technical background with sound product knowledge.

• You have knowledge of Regulations pertaining to the environment (i.e. ISO 13485, GDP, GMP, others) and demonstrated thorough E2E understanding for lifecycle management.

Leadership

• You are a pragmatic decision maker with the ability to move forward without a perfect solution.

• You are an excellent communicator with strong presentation, and negotiation skills. You have an agile mindset and demonstrate new ways of working.

• You have experience in leading cross-functional teams (Squad Lead, Matrix Lead) and driving change.

• You inspire the organization to think in terms of impact and outcomes rather than tasks and serve as a role model, exhibiting behaviors that support the transition to a new operating model emphasizing agility, collaboration, and adaptability.

Locations

You are located in Tucson, Arizona.

Relocation benefits are available for this position.

The expected salary range for this position based on the primary location of Arizona is $98,900 and $208,000. 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.