R&D Quality Manager (Medical Devices and/or Combination Products)
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Job Overview
The R&D Quality Manager will be responsible for maintaining regulatory files, supporting health authority inspections, developing quality plans, and ensuring compliance across operational activities. The role involves quality improvement initiatives, root cause analysis, CAPA development, and managing quality aspects of projects involving third parties, equipment, and manufacturing processes.
Key Responsibilities
* Support regulatory file maintenance and health authority inspection management.
* Develop and review quality and safety plans for clinical programs.
* Implement quality performance and compliance initiatives, including risk management and IT systems.
* Identify quality issues, conduct root cause investigations, and develop CAPA plans.
* Assist in deviation remediation and monitor corrective actions.
* Review and approve quality deliverables, report adverse events, and manage quality aspects of projects.
Key Performance Indicators
* Effective quality system management and audit issue resolution.
* Leadership in GxP practices and external engagement.
* Financial acumen in cost management and budgeting.
Minimum Requirements
Work Experience: Functional breadth, critical negotiations, project management, cross-boundary collaboration.
Skills: Agility, analytical skills, audit management, business partnering, change control, continuous learning, health authority knowledge, influencing skills, CAPA knowledge, QA, risk management, root cause analysis, self-awareness, Six Sigma, SOP, technological expertise.
Languages: English
Additional Details
* Seniority level: Mid-Senior level
* Employment type: Full-time
* Job function: Research, Analyst, and Information Technology
* Industry: Pharmaceutical Manufacturing
This job posting is active. No indication of expiration is provided.
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