Associate Director, Risk based Quality Management (secondment & permanent)

ABOUT ASTRAZENECAAt AstraZeneca, we are united by a common purpose: to push the boundaries of science to deliver life-changing medicines. Every day, we make a difference by delivering potentially life-changing medicines to millions of people worldwide. Our purpose is results-oriented and so is our approach. Becoming a more agile and creative company means building a dynamic, inspiring culture where we celebrate diverse, bold thinking, are curious, creative, and open to new insights and ways of working. JOB ROLEAssociate 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, Senior Specialist RbQM and Centralized Monitoring (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 Senior Specialists 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.The role is available for both permanent and secondment (end date 31st of May 2025) position. ACCOUNTABILITIES:Leads RbQM process in eligible studiesActs as subject matter expert (SME) in area of RbQM and risk management both internally and externallyDemonstrates good understanding of a broader CM strategy and contributes to it by driving cross functional innovation/optimization projectsMaintains a high level of understanding of regulatory agencies and other external and internal stakeholders’ requirements in terms of data qualityEngages 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 strategiesDevelops, coaches, mentors, motivates and inspires individuals within the CM organization especially in the therapy area of interestMay oversee activities performed by Senior Specialist, RBQMContributes to the development of CM methodology and CM best practicesExpected to coach more junior staff and support functional development through e.g. recruitment, training and mentoringActs as SME on RbQM/CM in AZ optimization/best practices initiativesESSENTIAL EXPERIENCE/SKILLS:Education: Minimum of a BSc degree in Life ScienceMinimum of 4 years of experience in the Biotech/Pharma/CRO industryHas a deep understanding of the clinical development and risk based monitoring and Centralised monitoring methodologiesAbility to define and lead improvement, innovation projects and interact with internal and external stakeholders at senior levels of managementExcellent communication skills in both written and spoken EnglishStrong Project Management and Risk Management skillsAbility to mentor, train and lead teams in projects Agile responsiveness to industry and business needs and embracing peers’ reviewDemonstrates strong cross-functional leadership skillsDESIRABLE:Experience in Risk Based Monitoring/Centralised Monitoring is highly desiredWorking in roles with global remitExcellent understanding and demonstration of the AZ values and behavioursJoin AstraZeneca and help us deliver life-changing medicines. Be among our employees who continue to make us an innovation-driven company that stands firmly among the world’s leaders in biopharmaceuticals. APPLY!Date Posted22-kwi-2024Closing Date06-maj-2024