R&D Quality Lead
Roche
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
In Pharma Development Quality (PDQ) we strive for confidence in the integrity of our data and our processes, agility, and unrivaled transparency with health authorities, patients and society. Our work provides leadership, know-how and partnering on quality across Molecules (GCP), Products (Drug and/or Medical Devices), Pharma affiliates and global regulated processes.
We are looking for an experienced Quality Lead to join our Quality Assurance Process team who will bring a diversity of thinking and technical experience in Quality disciplines but with a focus on GCP.
Key Responsibilities:
Lead and shape quality assurance initiatives focused on GCP, MDR, RBQM, Risk Management, and QMS
Manage large-scale projects within a matrix environment, driving decisions and clear communication
Use your digital and data literacy to inform quality strategy and improve process integrity
Apply critical thinking to identify and address quality risks in clinical trial processes
Oversee inspection readiness and lead inspection management activities with confidence
Navigate and resolve complex or high-impact quality issues, escalating where appropriate
Contribute to and lead quality assessments, audits, and timely reporting of findings
Prepare and deliver Quality conclusions, clearly communicating compliance risks and ensuring action plans are aligned with regulatory expectations
Who You Are
You’re a proactive, pragmatic critical thinker who thrives in complex, regulated environments. You bring both technical depth and strategic insight to quality assurance, and you’re energized by collaboration and impact.
You have a solid educational background in life sciences or a related scientific field, combined with professional experience in the pharmaceutical or healthcare industry
You have solid experience in GCP and a strong understanding of clinical trials and supporting regulations
You’ve led projects in matrixed teams and are comfortable influencing senior stakeholders
You’re skilled in problem-solving and decision-making, using curiosity and creativity to tackle challenges
You’re experienced in inspection readiness, managing inspections, and resolving critical quality issues
You have strong communication skills and the ability to translate data into actionable insights
Please provide your current compelling CV & Cover Letter. The interview process will include a case study presentation as part of the interview process.
The role will be based at our Welwyn or Mississauga sites. Please note that we are not able to provide any relocation benefits.
Some travel may be required to support inspections.
We are looking forward to your application!
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.
The statements herein are intended to describe the general nature and level of work being performed by employees, and are not to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. Furthermore, they do not establish a contract for employment and are subject to change at the discretion of Roche Products Ltd. At Roche Products we believe diversity drives innovation and we are committed to building a diverse and flexible working environment. All qualified applicants will receive consideration for employment without regard to race, religion or belief, sex, gender reassignment, sexual orientation, marriage and civil partnership, pregnancy and maternity, disability or age. We recognise the importance of flexible working and will review all applicants’ requests with care. At Roche difference is valued and we are proud to be an equal opportunity employer where you are encouraged to bring your whole self to work.