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 supporting business relationships with defined stakeholder groups in Development, Regulatory and Safety and for the delivery of risk-based GCP quality management activities for these stakeholders.
You will be responsible for:
Support the execution of the overarching strategy related to proactive and sustainable quality and compliance for all programs/portfolio for assigned Therapeutic Area(s) (TAs).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 Ops stakeholders and other functions such as Risk-based Quality Management.Support global/systemic clinical quality issue investigations, which includes leading Quality Event reportability assessments, investigations, and Root Cause Analysis in collaboration with issue owners.Perform Quality Event risk assessments and trending (deviations, audit findings, inspection findings, etc.) to determine robust CAPAs.Act as quality approver for Quality Issues and CAPAs as assigned.Support inspection readiness for assigned programs/portfolio including providing 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, Mock inspection, etc.).Support follow-up and tracking of inspection commitment and effectiveness checks for assigned programs/Therapeutic Area.Support continuous improvement and knowledge management by sharing case studies/lessons learned from QA activities to minimize recurrence of similar issues.Support in meetings driving quality and business performance.You will need to have:
Bachelor's degree in life science, or equivalent field, required.Minimum of 6+ 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 the business environment.Ability to maintain and create professional networks with stakeholders.Excellent communication skills; fluent oral and written English.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: 10-jul-2024
Closing Date: 05-sept-2024
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 us. Alexion participates in E-Verify.
#J-18808-Ljbffr
