Job type full-time
Full job description
Job title : associate director, risk based quality management
Career level: e
Leverage technology to impact patients and ultimately save lives
Do you have expertise in, and passion for, information technology? would you like to apply your expertise to impact the it strategy in a company that follows the science and turns ideas into life changing medicines? if so, astrazeneca might be the one for you!
Astrazeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines for some of the world’s most serious diseaseBut we’re more than one of the world’s leading pharmaceutical companiesAt astrazeneca we’re dedicated to being a great place to work.
About our it team
It’s a dynamic and results-oriented environment to work in – but that’s why we like itThere are countless opportunities to learn and grow, whether that’s exploring new technologies in hackathons, or redefining the roles and work of colleagues, foreverShape your own path, with support all the wayDiverse minds that work cross- functionally and broadly together.
About the role
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 safetyAd 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
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.gRecruitment, training and mentoring • acts as sme on rbqm/cm in az optimization/best practices initiatives
Education, qualifications, skills and experience
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
Experience in risk based monitoring/centralised monitoring is highly desired • working in roles with global remit • excellent understanding and demonstration of the az values and behaviours
Why join us ?
We’re a network of high-reaching self-starters who contribute to something far biggerWe enable astrazeneca to perform at its peak by delivering premier technology and data solutions.
We’re not afraid to take ownership and run with itEmpowered with unrivalled freedomPut simply, it’s because we make a significant impactEverything we do matters.
So, what’s next?
Are you already envisioning yourself joining our team? good, because we’d love to hear from you! click the link to apply and we’ll be in touch as soon as we can.
Where can i find out more?
Our social media, follow astrazeneca on linkedin https://www.linkedin.com/company/1603/
We are an equal opportunity employer and value diversity at our companyWe do not discriminate on the basis of race, religion, color, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status.
Posted 20 days ago