Associate Director, Risk Based Quality Management
Primary Location: Mississauga, Canada
Secondary Location: Dublin, Ireland
Hybrid Work Approach:
We help you balance your life and work needs. You'll spend an average of 3 days a week at our Mississauga head office (QEW and Cawthra), where you can connect, plan, and collaborate with your team. In-person days of the week and times of day are flexible and can be confirmed with your leader. Our office is designed for teamwork and creativity, making it easy for everyone to work together on important projects.
Some opportunities happen only once in a lifetime - like a job where you have the chance to change lives. At Alexion, people living with rare and devastating diseases are our Guiding Star. We are driven to continuously innovate and create meaningful value in all we do to help patients and families fully live their best lives. We value the uniqueness and diversity of our employees and recognize that nurturing the diverse perspectives and strengths of our people translates into innovative breakthroughs for patients.
This is what you will do:
Associate Director, Risk based Quality Management (AD RbQM) drives RbQM process in assigned studies or projects to ensure compliance with ICH-GCP R2, AZ SOPs and to safeguard clinical trial integrity and patient’s safety. AD RbQM works closely with Global Project and Study teams, SrS RbQM and CM Clinical Data Scientists at the initial stages of the studies to define critical to quality factors, quality tolerance limits and risk management strategies as well as coordinates and oversees work of SrSs RbQM and CM Data Scientists to define and execute Centralised monitoring support in eligible studies/projects. AD RbQM contributes to RbQM process and CM strategy by driving standardization and defining best practices
You will be responsible for:
- Leading Risk-based Quality Management (RbQM) process throughout the life of a clinical study.
- Ensuring compliance with ICH-GCP and AZ SOPs and maintain a high level of understanding of regulatory agencies requirements in terms of data quality
- Engaging project teams during initial stages of studies to identify study specific critical to quality factors, quality tolerance limits and risk management strategies
- Driving standardization and best practices in RbQM.
You will need to have:
- BSc in Life Science.
- 4+ years in Biotech/Pharma/CRO.
- Expertise in clinical development and risk based monitoringor central monitoring on clinical trials.
- Strong communication and project management skills.
- Ability to mentor, lead, and adapt to industry changes.
- Demonstrates strong cross-functional leadership skills and stakeholder management