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Senior Manager, Development Asset Quality Specialist
hace 2 meses
Job Summary
We are seeking a highly skilled and experienced Senior Manager, Development Asset Quality to join our team at La Esperanza Child Development Center, Llc. This is a critical role that will drive Quality Culture with Development, Regulatory, and Safety stakeholders, through learning, embedding a quality mindset, and executing on continuous improvement opportunities.
Key Responsibilities
- 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 develops mechanisms of KQI/KRI, detection, oversight, and trending with Clin development and Ops stakeholders and other stakeholders and functions such as Risk-based Quality Management
- Support global/systemic clinical quality issue investigations, which includes:
- In collaboration with issue owners lead 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
- Support inspection readiness for assigned programs/portfolio including but not limited to:
- Provide 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 check 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
Requirements
- 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 business environment
- Ability to maintain and create professional networks with stakeholders
- Excellent communication skills; fluent oral and written English
Preferred Qualifications
- 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
