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 PositionAt Roche, we advance science so that we all have more time with the people we love. In Pharma Development Quality (PDQ), we strive for confidence in the integrity of our data and processes, agility, and unrivalled transparency with health authorities, patients, and society.
The OpportunityAre you ready to shape the future of quality management in healthcare? As a Quality Lead within our Pharma Development Quality division, you will support the Roche/Genentech organisation by developing and delivering robust Quality Assurance strategies, audits, and conclusions across molecules in development, post-approval products, and global processes. You will act as a trusted partner, ensuring our operations maintain the highest standards of compliance while directly influencing how we bring innovative therapies to patients safely and efficiently.
In this dynamic role, you will apply a risk-based approach to Quality Assurance using our Critical to Quality (CtQ) framework. By generating actionable data and insights through audits, you will collaborate closely with international stakeholders and play a vital part in preparing for and supporting regulatory authority inspections. This is an exceptional opportunity to utilise your expertise in a truly global, agile matrix environment where your insights drive continuous improvement.
Key Responsibilities:
Drive Quality Strategies: Support the execution of risk-based Quality Assurance strategies and conclusions in predominantly Good Pharmacovigilance Practice (GVP) as well as Good Clinical Practice (GCP), using the Critical to Quality (CtQ) framework.
Lead Global Audits: Plan, perform, and lead audits, grouping individual issues into systematic trends to provide valuable quality data that fulfils regulatory requirements.
Partner with Stakeholders: Establish and maintain strong partnerships with business stakeholders, presenting audit observations and associated compliance risks clearly.
Support Inspections: Play a key role in regulatory authority inspection preparation and management.
Advance PDQ Processes: Participate actively in assigned departmental goals and initiatives, contributing directly to the continuous improvement of PDQ processes.
Maintain GxP Expertise: Maintain deep awareness and expertise in global regulations (such as FDA, EU, and ICH guidance) across GCP, GVP, or Medical Device frameworks.
You are a proactive, analytical quality professional who thrives on transforming complex data into clear, actionable solutions. You are an excellent communicator, highly skilled at collaborating across cultures and influencing stakeholders at various levels with or without formal authority. You look for opportunities to develop your skills within an international team and are passionate about continuous growth.
To be successful in this role, you bring:
Education: A Bachelor’s degree or equivalent in a scientific or quality-related field, or equivalent combined experience.
Industry Experience: Proven experience within the pharmaceutical, biotech, or medical device industry, with solid knowledge of end-to-end product operationalisation.
GxP Knowledge: Strong exposure to and understanding of global GxP regulations and quality roles, specifically within GCP, GVP, or IVD/MD frameworks.
Data & Digital Literacy: Excellent digital capabilities, with a good understanding of audit management and analytical reporting tools to drive data-led solutions.
Critical Thinking: Proven problem-solving, decision-making, and project management skills with the ability to navigate ambiguous information.
Location
This position must be based in either Basel, Switzerland, Mississauga, Canada or South San Francisco, US. Although this can be a hybrid role, with an expectation of ongoing and sustained site presence, in compliance with local company site requirements
International business travel may be required. Typically, this will be required about 10% of the time, depending on the role's requirements.
#MQRS
Relocation benefits are not available for this position
Scientific rigour and creativity, inclusive teamwork and exceptional delivery are key behaviours that drive our mission of doing now what patients need next. Together, we can be transformative.
Where pay transparency applies, details are provided based on the primary posting location. For this role, the primary location is Basel. If you are interested in additional locations where the role may be available, we will provide the relevant compensation details later in the hiring process.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.
