Alexion] Associate Director, Development Clinical Quality

Emploi Corée

Titre du poste : Alexion] Associate Director, Development Clinical Quality

Entreprise : 아스트라제네카

Description du poste : [Key Accountabilities]As part of the Development Quality Team, you will drive Quality Culture with Development, Regulatory and Safety stakeholders, through learning, embedding a quality mindset, and executing o continuous improvement opportunities. You will be responsible for managing business relationships and delivery of a GCP risk based robust quality management activities. Assisting in the development of an overarching strategy related to proactive and sustainable quality and compliance for all programs/studies at a country level.Work with cross functional and other quality partners to proactively identify study level Key Quality and Risk Indicators (KQIs/KRIs) and develops mechanisms of KQI/KRI, detection, oversight and trending.Serve as the quality expert for Quality Events at a country/ regional (if needed).Be accountable for leading inspection readiness at local level and providing input to global inspection readiness.Supporting local/ global teams (if needed) on risk-based approach in implementation of current routine quality management work.Provide advice to local/ global (if needed) teams to ensure that processes and procedures are compliant with AZ procedures, international GXP requirements and relevant legal regulations.[Qualifications]Minimum of 8+ years of experience in clinical research area inclusive of, but not limited to, Good Clinical Practice or Good Clinical Practice quality assurance and complianceEstablished knowledge of GxP/GCP regulations and guidelines (EMA, FDA, PMDA etc.)Significant experience with GxP investigations, risk assessments and CAPA managementExperience participating in regulatory inspectionsFunctional planning experience and ability to develop functional vision, priorities and tacticsExperience with multinational products and regulations as well as with mandated risk management plansAbility to travel up to 20% or more as neededThe duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.Date Posted 08-6월-2025Closing DateAlexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation, please contact . Alexion participates in E-Verify.

Salaire attendu :

Localisation : 서울시

Date du poste : Sun, 08 Jun 2025 22:58:32 GMT

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