Senior Quality Systems Expert CGT

Roche•Mississauga, ON

2d•$136,936 - $179,729

About 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.

Requirements

Bachelor’s or postgraduate degree in a Life Sciences, Pharmacy, Engineering, or related science discipline.
Over 10 years of experience in the Pharma/Biopharmaceutical industry, specifically with ATMPs manufacturing.
Experience in aseptic operations, Biologics, or analytics is an advantage.
Strong knowledge of GxP regulations to clinical and commercial products to ensure patient safety and the appropriate level of compliance.
Ability to manage ambiguity through effective communication, skillfully removing barriers, and overcoming resistance.
Ability to operate autonomously and manage complex situations by successfully coordinating multiple tasks and prioritizing them to deliver optimum results.
High integrity and accountability, ensuring team's actions and decisions are aligned with business objectives.

Responsibilities

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.
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.
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.
Liaise with production activities, including Apheresis collection, AAV plasmid production, Drug Substance/Product manufacturing, analytics, and shipment to treatment centers.
Coordinate work across systems, functions, and sites to harmonize workflow and optimize cross-functional team member participation.
Lead the development, review, and revision of SOPs and procedural documents, and collaborate on updating curricula based on determined training needs.
Monitor the implementation and effectiveness of systems, create Quality Management Review metrics, and foster continuous quality improvement and procedural simplification.
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.