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 

Date Posted

Closing Date

Alexion 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 accommodations@Alexion.com. Alexion participates in E-Verify.