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R&D Quality Manager (Medical Devices and/or Combination Products)

Sandoz · Posted Jun 25, 2025

Cambridge, Cambridgeshire, United Kingdom
Manager

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Provide quality assurance expertise, guidance and support to operational activities in development and research organizations to ensure compliance with applicable regulatory requirements and Novartis procedures and quality standards.

Responsibilities

Support maintenance of the regulatory-required files for health authority inspections and assist with health authority inspection management
Support generation of Quality Plans (and review other plans for quality/safety aspects) for clinical programs
Support initiatives to maintain or improve quality performance and compliance of operational activities including risk management, health authority reporting, IT systems
Support initiatives focused on quality, process and compliance improvement, including identification of opportunities and develop strategies aimed at improving quality while ensuring compliance with regulatory requirements
Ensure information gained during quality and compliance initiatives, as well as audit and assessment results, are evaluated to identify any regulatory, compliance and QA training needs

Requirements

Nice to have: Agility
Nice to have: Analytical Development
Nice to have: Business Partnering
Nice to have: Continuous Learning
Nice to have: Influencing Skills

Skills

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Compensation

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R&D Quality Manager (Medical Devices and/or Combination Products)

Responsibilities

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