Associate Director, Development Country Quality (Alexion)

Associate Director, Development Country Quality (Alexion)

Location: Warsaw, hybrid work (3 days from the office, 2 days from home/weekly)

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 country 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 (local) 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:

• Bachelor’s 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 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.  

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