Quality & Process Manager

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 role of the Quality & Process Partner is to support Clinical Operations (CO) strategic directives by ensuring the proactive development and management of optimal business processes that enable compliance and highest quality standards are met. The postholder will collaborate with stakeholders within Research and Early Development (pRED) and across the enterprise, as well as represent CO in the respective areas of Process Management as well as Quality and Compliance as it relates to GCP/GVP.

You will be primarily responsible for:

• Providing strategic oversight and direction on how best to address all quality issues arising from pRED studies (via audits or otherwise) and ensures action plans are created and implemented to address findings. Ensures learning from audits are consistently shared within all applicable areas of pRED Clinical Operations and DTAs
• Functioning as the content expert for Quality & Processes across all relevant pRED Clinical Operations and DTAs groups, this includes the proactive identification of risks and proposal for risk mitigation strategies. Providing the required support during HA inspections and internal audits, including leading CAPA related activities
• Developing and executing continuous improvements as they relate to processes and audit/inspection findings
• Developing and maintaining metrics in the relevant areas (eg quality and productivity measures)
• Ensuring pRED Quality Management System (QMS) activities are aligned with global GCP/GVP QMS
• Staying abreast of internal and external developments, trends, and other dynamics relevant to the work of Clinical Operations
• Collaborating with colleagues across chapters and the Roche Enterprise to ensure fit for purpose processes

In Clinical Operations Mindset and behaviour is as important to us as skills and capabilities

• Connect with the bigger picture, prioritize Roche, pRED or wider team over Function and individual, apply enterprise view
• Collaborative and creative mindset, ability to partner inside and outside Roche
• The statements made in the job description are intended to describe the general nature and level of work being performed by people assigned to this job. These statements are not intended to be an exhaustive list of responsibilities, duties and skills required of the people assigned to this job
• Show and embrace agile behavior
• Follow a logic of incrementally improving approaches and solutions (80/20 approach where applicable/ MVPs/ iterate)
• Stand in the shoes of stakeholders and able to build strong customer relationships
• Ability to cope with uncertainty and manage ambiguity
• Empowerment and accountability
• Take ownership and accountability
• Empower people to contribute according to their skills, capacity and interest
• Decisions are made by the most appropriate person on the topic
• Foster a speak‑up culture
• Demonstrate a growth mindset
• Give, seek and receive constructive feedback
• Openly and proactively share information, failure, ideas, experience and learnings with others
• Drive innovations and foster the power of experimentation
• Create value in an agile organization by increasing our focus on playing the role of Visionary, Architect, Coach and Catalyst
• As a visionary, you facilitate the creation of a bold, shared vision and higher purpose that is co‑create with customers to advance a vision
• As an Architect, you seek value creation across the whole organisation, shaping organisational architecture and culture
• As a Coach you help everyone in the network build the skills and mindsets they need to succeed in an empowered system, acting as a role model and coach, with a willingness to be coached
• As a…