Summary
As our Associate Director External Service Provider QA, you'll oversee the implementation of quality standards, processes, and systems. You will manage external service providers supporting Novartis Global Clinical Trials in R&D Quality, ensuring high standards of excellence.
About the Role
Primary Location: London, United Kingdom
Secondary Location(s): Barcelona, Spain; Madrid, Spain; Dublin, Ireland
Working model: Hybrid (12 days per month in the office)
Key Responsibilities:
1. Review and approve ESP qualification for global clinical trials.
2. Negotiate and execute Quality Assurance Agreements with ESPs.
3. Review and approve QRAs to identify risks and issues proactively.
4. Manage quality issues related to ESPs and escalate critical issues; support breach assessments and reporting.
5. Evaluate and assess technology like SaMD, DHT, SaaS for regulatory compliance.
6. Support trial-specific technology assessments to ensure fit for purpose.
7. Facilitate 'Quality with Technology' discussions to enhance understanding and collaboration.
8. Represent ESPQA in digital and IT projects, managing third-party quality activities.
9. Participate in technology implementation reviews for inspection readiness.
10. Ensure inspection readiness and support audits and inspections related to ESPs.
Role Requirements:
Experience: 12+ years in pharmaceutical development; knowledge of quality management, clinical operations, and vendor management preferred.
Education: Bachelor's degree in Life Sciences, Pharmacy, Medicine, or related field.
Languages: Fluent in English.
Skills & Expertise: Knowledge of GCP/GLP, GMP, GVP; leadership in quality systems; experience managing ESPs; familiarity with IRT, eCOA, Imaging; understanding of quality systems, clinical trials, and digital validation; stakeholder engagement and root cause analysis skills.
Why Novartis:
Join us to help people with diseases, collaborate with passionate colleagues, and achieve breakthroughs that change lives. Learn more: https://www.novartis.com/about/strategy/people-and-culture
Join our Novartis Network:
Stay connected and learn about opportunities: https://talentnetwork.novartis.com/network
Benefits and Rewards:
Discover how we support your growth: https://www.novartis.com/careers/benefits-rewards
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