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
Local Quality Responsible (LQR)
A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love.
That’s what makes us Roche.
LQRs collaborate with Affiliate and Global colleagues to proactively enable Affiliate business while providing a quality framework for a healthy Affiliate QMS that protects patient safety, ensures reliability of Roche’s data and maintains the company’s license to operate while driving continuous improvement.
The Opportunity
The Local Quality Responsible (LQR) leads the implementation of Roche’s Global Quality Management System (QMS) at the affiliate level, ensuring alignment with regulatory requirements and local business needs. This role drives the execution of global and local quality strategies, manages CAPA processes, and proactively identifies trends and risks to support continuous improvement. The LQR also oversees local training strategies aligned with global QMS training processes, ensures effective lifecycle management of procedural documents, and monitors regulatory changes to ensure timely local implementation. Additionally, the LQR partners with internal stakeholders to maintain compliance in records management and ensures appropriate oversight of service providers in accordance with global directives.
Leads the oversight of Affiliate Medical Compliance by measuring overall compliance status and driving necessary actions to address any gaps. This includes leading Affiliate Management Reviews (MRs) and the Local Medical Compliance Office (LMCO), ensuring that outcomes are clearly communicated to senior management for informed decision-making. The LQR also ensures that critical insights related to QMS health are appropriately escalated to global functions, in alignment with the established Medical Compliance governance model.
Lead the Risk & Opportunity management and escalation process at local level to proactively identify, manage, mitigate and escalate Medical Compliance risks. As well as contribute to the delivery of quality solutions through collaboration with business partners and other functions to support effective risk minimization and identify opportunities to create a competitive advantage for the organization.
Lead Affiliate Quality Monitoring by identify the need for establishing an affiliate quality monitoring strategy in collaboration with relevant local and global stakeholders, in the areas of QMS and Medical Compliance. As applicable, design, lead and/or execute the Affiliate Quality Monitoring strategy in collaboration with local and global stakeholders in order to proactively identify and mitigate potential risks.
Supports audits and inspections impacting the affiliate by contributing local insights to the PDQ Quality Assurance global strategy. This role coordinates and supports the preparation, execution, and CAPA response for audits and inspections related to QMS and GCP/GVP compliance, in collaboration with PDQ. Additionally, the LQR leads inspection readiness activities and initiatives to ensure the affiliate is fully prepared for GCP/GVP inspections as needed.
Undertake other quality responsibilities that may arise in emerging Quality areas (e.g. Healthcare Solutions, RWE, medical devices) as per business needs, work packages and/or as defined in local/global procedures, systems, regulations and requirements.
Who you are
You should hold a Bachelor Degree in Life Science or with more than 5 years experience in a biopharmaceutical company or equivalent
You should have strong business acumen with demonstrated expertise in QMS, Medical Compliance, Service Provider Oversight, CAPA and Risk Management, process simplification. As well as demonstrated applied knowledge of ICH GCP, GVP and other relevant regulations and requirements, at a global and local level
You should have understanding the Quality Principles of ISO standards (e.g ISO 9001 Quality Management System & ISO 31000 Risk Management and ISO 13485 Medical Devices) with experience in working with a cross-functional team and international network, preferably in a GxP function
You should have experience/involvement in audits (and Health Authority inspections).
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.
