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Associate Director, Development Asset Quality
hace 2 meses
Join Importante empresa as an Associate Director, Development Asset Quality and drive quality culture with Development, Regulatory, and Safety stakeholders.
About the Role:This is a unique opportunity to lead Quality Culture with Development, Regulatory, and Safety stakeholders through learning, embedding a quality mindset, and executing on continuous improvement opportunities.
Key Responsibilities:- Develop an overarching strategy related to proactive and sustainable quality and compliance for all programs/portfolio for assigned Therapeutic Area(s) (TAs).
- Represent DAQ on Alexion Global Program Teams (GPTs) and Regulatory Strategy Teams (RSTs) to proactively identify critical to quality risks and mitigation strategy to drive excellence in study execution and minimize risk to regulatory submission/approval.
- Work with cross-functional and other quality partners to proactively identify study level Key Quality and Risk Indicators (KQIs/KRIs) and develop mechanisms of KQI/KRI detection, oversight, and trending with Clinical Development and Ops stakeholders.
- Serve as the quality expert for global/systemic clinical quality issue investigations, including leading 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.
- Act as quality approver for Quality Issues and CAPAs as assigned.
- Lead inspection readiness for assigned programs/portfolio, 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 commitments and effectiveness checks for assigned programs/Therapeutic Area.
- Serve as the Subject Matter Expert (SME) and provide guidance on major processes/platforms optimization and quality governance requirements where applicable (e.g., TMF health oversight, CRO/Vendor oversight, medical device requirements, etc.).
- 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.
- 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 10%.
- Advanced degree preferred.
- Quality, process, and compliance oriented.
- Strong interpersonal skills.
- Critical thinking.
- Integrity.
- Communication.
- Teamwork.
- Problem solving.
