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Associate Director, Risk based Quality Management

Location Mississauga, Ontario, Canada Job ID R-116927 Date posted 27/09/2021

About AstraZeneca:

AstraZeneca is a global, innovation-driven Biopharmaceutical business that focuses on the discovery, development and commercialization of prescription medicines for some of the world’s most serious disease. But we’re more than one of the world’s leading pharmaceutical companies.

 At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration. Always committed to lifelong learning, growth and development.

AstraZeneca Canada:

Headquartered in Mississauga, Ontario, we’ve been recognized as one of Greater Toronto Area’s Top Employers for 7 straight years. Our collaborative work environment fosters knowledge-sharing, decision-making, and entrepreneurial thinking. Our employees have the opportunity to work across teams, functions, and even the globe. With a commitment to sustainability, we’re working towards making a meaningful impact where society needs it — health. We know the health of people, the planet and our business are interconnected, each impacting the others.

Our dynamic culture truly sets us apart. We support our people every day, focusing on three priorities: employee growth & development, health & wellbeing, and cultivating a vibrant, engaged and energized workplace. Through practical tools, resources, inspiring learning opportunities, and health and wellness support, we are helping our people thrive at work and beyond.

Our Biopharmaceuticals Research and Development Team:

Join the team unlocking the power of what science can do. We are working towards treating, preventing, modifying and even curing some of the world’s most complex diseases. Here we have the potential to grow our pipeline and positively impact the lives of billions of patients around the world.

Thrive in a place where the brightest and most curious minds seamlessly come together in our inclusive environment. It’s a place to think differently – to find new ways of handling and treating diseases. We are trusted and empowered to explore.

What you’ll 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

Typical Accountabilities:

  • Leads RbQM process in eligible studies

  • Acts as subject matter expert (SME) in area of RbQM and risk management both internally and externally

  • Demonstrates good understanding of a broader CM strategy and contributes to it by driving cross functional innovation/optimization projects

  • Maintains a high level of understanding of regulatory agencies and other external and internal stakeholders’ requirements in terms of data quality

  • Engages project teams, global and local study steams during initial stages of studies in order to develop study specific critical to quality factors, acceptable defect rates, quality tolerance limits and risk management strategies

  • Develops, coaches, mentors, motivates and inspires individuals within the CM organization especially in the therapy area of interest

  • May oversee activities performed by Senior Specialist, RBQM

  • Contributes to the development of CM methodology and CM best practices

  • Expected to coach more junior staff and support functional development through e.g. recruitment, training and mentoring

  • Acts as SME on RbQM/CM in AZ optimization/best practices initiatives

  • Responsible for collecting and reporting Adverse Events in accordance with AstraZeneca policies and procedures

Qualifications:

  • Education: Minimum of a BSc degree in Life Science

  • Minimum of 4 years of experience in the Biotech/Pharma/CRO industry

  • Has a deep understanding of the clinical development and risk based monitoring and Centralised monitoring methodologies

  • Ability to define and lead improvement, innovation projects and interact with internal and external stakeholders at senior levels of management

  • Excellent communication skills in both written and spoken English

  • Strong Project Management and Risk Management skills

  • Ability to mentor, train and lead teams in projects  

  • Agile responsiveness to industry and business needs and embracing peers’ review

  • Demonstrates strong cross-functional leadership skills

Great People want to Work with us! Find out why:

  • GTAA Top Employer Award for 7 years:https://reviews.canadastop100.com/top-employer-astrazeneca-canada

  • Best Workplace Culture Award at the 2018 Canadian HR Awards:https://www.linkedin.com/pulse/thriving-best-workplace-culture-gena-restivo/

  • Browse AstraZeneca's YouTube channel to find out more about us:https://www.youtube.com/user/astrazeneca


Are you interested in working at AZ, apply today!

AstraZeneca is committed to taking every reasonable precaution to protect employees, our customers and the healthcare systems in the communities in which we serve. In an effort to protect the wellbeing of our employees and customers, full COVID-19 vaccination is an essential requirement of all positions at AstraZeneca. As such, all offers of employment will be conditional upon either (i) proof of full COVID-19 vaccination or (ii) proof of need for accommodation under relevant human rights legislation, and AstraZeneca’s determination that the requested accommodation can be provided without undue hardship.  You will be required to submit proof of full vaccination or proof of need for accommodation during our background screening process.

AstraZeneca is an equal opportunity employer that is committed to diversity and inclusion and providing a workplace that is free from discrimination.AstraZenecais committed to accommodating persons with disabilities. Such accommodation is available on request in respect of all aspects of the recruitment, assessment and selection process and may be requested by emailing AZCHumanResources@astrazeneca.com.



AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.

50056688 E PRII R&D BioPharmaceuticals

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Glassdoor logo Rated four stars on Glassdoor

Great culture, great work assignments, supportive management. Rotation opportunity within the company. They value inclusion and diversity.