Associate Director, Development Asset Quality

at  AstraZeneca

ASSOCIATE DIRECTOR, DEVELOPMENT ASSET QUALITY

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of three days per week from the office. But that doesn’t mean we’re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.
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 on continuous improvement opportunities. You will be responsible for managing business relationships with defined stakeholder groups and senior leaders in Development, Regulatory and Safety and for the strategic development and delivery of a GCP risk based robust quality management activities for these stakeholders.

• Assisting in the development of an overarching strategy related to proactive and sustainable quality and compliance for all programs and/or countries assigned. Responsible to drive a culture of data and risk driven quality of clinical trials.
• 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 with Clin development and Ops stakeholders and other stakeholders and functions such as Risk based Quality Management
• Serve as the quality expert for global clinical quality issue investigations, which includes:
• In collaboration with issue owners lead Quality Event reportability assessments, investigations and Root Cause Analysis
• Perform Quality Event risk assessments and trending (deviations, audit findings, inspection findings etc.) to determine robust CAPAs
• Acts as quality approver for Quality Issues and CAPAs as assigned
• Be accountable for leading inspection readiness (global) for assigned programs/portfolio/countries including but not limited to:
• Provide leadership and guidance to team members in promoting a culture of inspection readiness and sustainable clinical compliance
• Provide guidance to team members in Inspection Readiness and Preparation Activities (e.g., SME training.)
• Support follow up and tracking of inspection commitment and effectiveness check for assigned programs/countries
• Serve as the Subject Matter Expert (SME) and provide guidance on major processes/platforms optimization and quality governance requirements
• Drive continuous improvement and knowledge management by sharing case studies/lessons learned from QA activities to minimize recurrence of similar issues
• Actively participate in meetings driving quality and business performance
• Support Due Diligence and integration activities as assigned