Associate Director Development Asset Quality

This is what you will do:

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.

You will be responsible for:

• 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

You will need to have:

• Bachelors degree in life science or equivalent field required
• 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 compliance
• Established knowledge of GxP/GCP regulations and guidelines (EMA FDA PMDA etc.
• Significant experience with GxP investigations risk assessments and CAPA management
• Experience participating in regulatory inspections
• Functional planning experience and ability to develop functional vision priorities and tactics
• Experience with multinational products and regulations as well as with mandated risk management plans
• Ability to travel up to 20 or more as needed
• The duties of this role are generally conducted in an office environment. As is typical of an officebased 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 nonlinear thought analysis and dialogue; collaborate with others; maintain general availability during standard business hours.

We would prefer for you to have:

• Advanced degree preferred

• Competencies to be successful for this position include:
  • Quality process and compliance oriented
  • Strong interpersonal skills
  • Critical thinking
  • Integrity
  • Communication
  • Teamwork
  • Problem solving

Date Posted

17Apr2025

Closing Date

08May2025Alexion 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 EVerify.