SENIOR MANAGER, DEVELOPMENT CLINICAL QUALITY

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! Date Posted 16-jul- Closing Date 20-jul- 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.
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