Strategic 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.

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 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 chemical/biological device development. Additional experience with computational aspects (ML, AI, SaMD, etc.) related to medical device development is a plus.

• 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 not available for this position.

The expected salary range for this position based on the primary location of Arizona is $101,850 and $213,000. 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

A healthier future drives us to innovate. Together, more than 100'000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.

Let's build a healthier future, together.

Roche is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.

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