Associate Director, QA for Third-Party Tech in Clinical Trials
Novartis UK
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Benefits offered by this job
Job summary
Novartis UK seeks an Associate Director External Service Provider QA to provide expert QA support in third-party due diligence, qualification and ongoing governance for tech-enabled services used in clinical trials.
The role involves overseeing DHT/SaMD/SaaS implementations, ensuring GxP compliance, and maintaining inspection readiness across global teams in a highly matrixed environment.
Qualifications
- Extensive experience in pharmaceutical development and quality management systems.
- Strong knowledge of GxP, GMP, GLP, and regulatory expectations.
- Experience with vendor management and third-party oversight in clinical trials.
- Proficiency in documenting, auditing and ensuring inspection readiness.
Responsibilities
- QA support for Third Party qualifications and governance as a QA SME.
- Identify risks with new Third Parties for GxP use and from exploratory to regulated use.
- Support clinical trial teams with trial-specific assessments for fit-for-purpose technology.
- Review quality issues and escalate major/critical problems; report to health authorities as needed.
- Lead Quality with Technology discussions with Third Party teams to resolve quality challenges.
Skills
Education
Job description
Novartis UK seeks an Associate Director External Service Provider QA to provide expert QA support in third-party due diligence, qualification and ongoing governance for tech-enabled services used in clinical trials.
The role involves overseeing DHT/SaMD/SaaS implementations, ensuring GxP compliance, and maintaining inspection readiness across global teams in a highly matrixed environment.
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