Roche

Strategic Quality Partner - Assay and Reagents

Rotkreuz Full time

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.

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, 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. You are an example of living collective success by working, trusting and empowering each other.

The Opportunity

  • Act as single point of contact within the project team (new product development / product change) and lead strategic topics and decisions to ensure business results and customer value.

  • Partner with Design Quality Partners (DQP) and stakeholders across the value chain to ensure efficient documentation, correct milestone deliverables, and accelerated development incorporating lessons learned.

  • Ensure consistent interpretation and implementation of global requirements across Customer Areas (CAs) and integrate post-market quality feedback and lessons learned into development requirements.

  • Ensure development project plans contain the required D&D module deliverables to provide safe, compliant, and high-quality solutions.

  • Support internal and external audits, ensure effective milestone reviews, and facilitate constructive discussions in project meetings.

  • Drive risk-based decision making by promoting the Risk Enabler, preparing decisions, and ensuring effective issue resolution (e.g., CAPA, NC).

  • Develop and enhance playbooks, feedback loops, and information flow to optimize and accelerate Pre-Market Quality contributions for different project types/technologies.

  • Embed and continuously improve knowledge management, change management, and information sharing across Pre-Market Quality, R&D, Product Development Quality, and other functions.

  • Foster a culture of innovation, continuous improvement, agility, collaboration, and adaptability, acting as a role model and coaching colleagues to grow and develop.

  • Drive effective decision-making, complexity reduction, pragmatic solutions, outcome-focused thinking, and continuous improvement across Customer Areas, including international travel as required.

Who you are

  • Bachelor’s degree in science, business administration, or related field (MBA or advanced degree preferred) with 8+ years of experience in the diagnostics industry or related business functions, combining strong business/financial acumen, enterprise mindset, and solid scientific/technical background with product knowledge; infectious disease expertise preferred.

  • Experience with regulatory requirements and submissions, including FDA / FDA submissions, and knowledge of applicable standards and regulations (e.g., ISO 13485, ISO 14971, GDP, GMP, environmental regulations), with demonstrated end-to-end

  • Strong decision-making capability with a pragmatic, solution-oriented mindset, ability to operate without perfect information, and strong agile knowledge demonstrating modern ways of working.

  • Excellent communication, presentation, and negotiation skills; proven leadership experience leading cross-functional and global matrix teams, driving change, and inspiring teams in line with Roche Values and Operating Principles.

  • Fluent English required; German is a strong plus (not mandatory); ability to influence globally and deliver transformative, customer-focused solutions while acting according to Roche Operating Principles (patients first, follow the science, act as one team, embrace differences, accelerate learning, simplify radically, make impact now, think long term).

Ready to take the next step? We'd love to hear from you. Apply now to explore this exciting opportunity!

 

 

Who we are

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.