Senior Manager, Development Asset Quality Specialist
hace 1 mes
This is a unique opportunity to drive Quality Culture with Development, Regulatory and Safety stakeholders at La Esperanza Child Development Center, Llc. As a key member of the Development Quality Team, 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:
- Supporting the execution of the overarching strategy related to proactive and sustainable quality and compliance for all programs/portfolio for assigned Therapeutic Area(s) (TAs)
- Supporting quality partners to proactively identify study-level Key Quality and Risk Indicators (KQIs/KRIs) and developing mechanisms for KQI/KRI detection, oversight, and trending with Clin development and Ops stakeholders and other stakeholders and functions such as Risk-based Quality Management
- Supporting global/systemic clinical quality issue investigations, which includes:
- Leading Quality Event reportability assessments, investigations, and Root Cause Analysis
- Performing Quality Event risk assessments and trending (deviations, audit findings, inspection findings, etc.) to determine robust CAPAs
- Acting as a quality approver for Quality Issues and CAPAs as assigned
- Supporting inspection readiness for assigned programs/portfolio, including but not limited to:
- Providing leadership and guidance to team members in promoting a culture of inspection readiness and sustainable clinical compliance
- Providing guidance to team members in Inspection Readiness and Preparation Activities (e.g., SME training, Mock inspection, etc.)
- Supporting follow-up and tracking of inspection commitment and effectiveness check for assigned programs/Therapeutic Area
- Supporting continuous improvement and knowledge management by sharing case studies/lessons learned from QA activities to minimize recurrence of similar issues
- Supporting 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 is a plus. 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.
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