Senior Quality Systems Expert CGT

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, 94,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity, and diversity.  We believe every employee makes a difference. We are passionate about transforming patients’ lives. We are courageous in both decision and action, we believe that good business means a better world.

You will provide strategic leadership and management to the Cell & Gene Therapy Quality Systems organization within PTQC. Accountable for the establishment and Quality oversight of the global tools, processes and procedures specific to Cell & Gene Therapy. Ensure the Quality tools, processes and procedures used in PTC are fit for purpose, GxP compliant and support Clinical development timelines as well as future commercial launch.

The Opportunity:

• You will partner with senior leadership to set the strategic direction and ensure alignment with Roche Quality and business strategies, developing and maintaining strong collaborations with internal and external partners.

• You will provide quality expertise and oversight for IT tools, business processes, and GxP procedures used by the PTC unit, ensuring they are phase-appropriate and fit for purpose for Cell & Gene Therapy production.

• You will liaise with production activities, including Apheresis collection, AAV plasmid production, Drug Substance/Product manufacturing, analytics, and shipment to treatment centers.

• You will coordinate work across systems, functions, and sites to harmonize workflow and optimize cross-functional team member participation.

• You will lead the development, review, and revision of SOPs and procedural documents, and collaborate on updating curricula based on determined training needs.

• You will monitor the implementation and effectiveness of systems, create Quality Management Review metrics, and foster continuous quality improvement and procedural simplification.

• You will support internal and external audits, manage deviations and complaints, provide timely support and author responses for Health Authority interactions, and ensure pragmatic, patient-centered problem solving.

Who you are :

• You will have a Bachelor’s or postgraduate degree in a Life Sciences, Pharmacy, Engineering, or related science discipline.

• You will possess over 10 years of experience in the Pharma/Biopharmaceutical industry, specifically with ATMPs manufacturing, with experience in aseptic operations, Biologics, or analytics being an advantage.

• You will apply strong knowledge of GxP regulations to clinical and commercial products to ensure patient safety and the appropriate level of compliance.

• You will manage ambiguity through effective communication, skillfully removing barriers, and overcoming resistance.

• You will operate autonomously and manage complex situations by successfully coordinating multiple tasks and prioritizing them to deliver optimum results.

• You will demonstrate high integrity and accountability, ensuring your team's actions and decisions are aligned with business objectives.

**Relocation benefits not available for this position**

The expected salary range for this position based on the primary location of Mississauga is 136,936.00 and 179,728.50 of hiring range. Actual pay will be determined based on experience, qualifications, and other job-related factors as determined by the company.

We use artificial intelligence to screen, assess or select applicants for this role.

This posting is for an existing vacancy at Hoffmann-La Roche Ltd.

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.