Associate Director External Service Provider Quality Assurance
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Role Overview
As Associate Director External Service Provider QA, you'll oversee the implementation of quality standards, processes, and tools. You will manage external service providers supporting Novartis Global Clinical Trials in R&D Quality, ensuring they meet high standards of excellence.
Key Responsibilities
* Review and approve ESP qualification for global clinical trials.
* Negotiate and execute Quality Assurance Agreements with ESPs.
* Review and approve QRAs to identify risks and issues proactively.
* Manage quality issues, escalation, and serious breach assessments.
* Collaborate with internal partners to ensure risk evaluation and communication.
* Monitor quality metrics, reporting, and follow-up actions.
* Ensure inspection readiness and support audits and inspections.
* Maintain compliance with GCP, GLP, GVP, GMP, and improve quality processes.
Minimum Requirements
* Bachelor’s degree in Life Sciences, Pharmacy, Medicine, or related field.
* 12+ years in pharmaceutical development with knowledge of quality management, clinical operations, and vendor management.
* Good knowledge of GCP/GLP, GMP, GVP.
* Leadership experience in implementing quality systems and standards.
* Experience managing ESPs and knowledge of regulatory standards; experience with IRT, eCOA, Imaging services is a plus.
* Technical understanding of quality systems and clinical trial processes.
* Skills in data analysis, trending, and collaboration.
* Fluent in English, written and spoken.
Novartis promotes an inclusive, diverse work environment and offers accommodations for individuals with disabilities. Learn more about our culture and benefits through the provided links.
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