International Quality Lead

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 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 Opportunity

Are 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.

Who You Are

You are a proactive, analytical quality professional who thrives on t...