Introduction to role:

Are you ready to make a significant impact in the world of clinical quality? As a key member of the Development Quality Team, you'll be at the forefront of driving a Quality Culture with Development, Regulatory, and Safety stakeholders. Your role will involve fostering a quality mindset, executing continuous improvement opportunities, and supporting business relationships with defined stakeholder groups. You'll be responsible for delivering risk-based GCP quality management activities, ensuring excellence in clinical trials.

Accountabilities:

• Support the execution of the 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.
• Support quality partners to proactively identify study-level Key Quality and Risk Indicators (KQIs/KRIs) and develop mechanisms for KQI/KRI detection, oversight, and trending with clinical development and operations stakeholders.
• Support global or local clinical quality issue investigations, including leading Quality Event reportability assessments, investigations, and Root Cause Analysis.
• Perform Quality Event risk assessments and trending to determine robust CAPAs.
• Act as quality approver for Quality Issues and CAPAs as assigned.
• Support inspection readiness for assigned programs/countries, providing leadership and guidance to team members in promoting a culture of inspection readiness and sustainable clinical compliance.
• Provide guidance in Inspection Readiness and Preparation Activities.
• Support follow-up and tracking of inspection commitments and effectiveness checks for assigned programs/Therapeutic Areas.
• Share case studies/lessons learned from QA activities to minimize recurrence of similar issues.
• Drive quality and business performance in meetings.

Essential Skills/Experience:

• Bachelor’s degree in life science, or equivalent field, required.
• Minimum of 5+ 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 GCP regulations and guidelines (EMA, FDA, PMDA etc.).
• Experience participating in regulatory inspections.
• Strong collaborative, influencing, and interpersonal skills – curious to understand business environment.
• Ability to maintain and create professional networks with stakeholders.
• Excellent communication skills; fluent oral and written English.

Desirable Skills/Experience:

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

At AstraZeneca's Alexion division, you will join a team that is dedicated to making a difference in the lives of patients with rare diseases. Our innovative spirit drives us to continuously adapt and move forward with urgency. We offer a unique environment where you can grow professionally while contributing to meaningful work that impacts patients' lives. Our culture fosters connections that inspire new ideas and learning opportunities. You will be supported by exceptional leaders who are committed to your development.

Ready to make an impact? Apply now!

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.