Associate Director ESP Quality
Core
Liaison between Novartis clinical trial teams and Third Parties to provide expert QA support during due diligence, qualification, and ongoing governance of technology-enabled services.
Role type
Senior IC Quality Assurance Manager (Third-Party & Technology)
Builds
Qualified and governed Third-Party vendor relationships for clinical trials
Domain
Pharmaceutical clinical trials / Digital Health Technology (DHT, SaMD, SaaS)
Required skills
Third-party vendor management, Quality Management Systems (QMS), GxP compliance, Risk monitoring, Audit support, SDLC validation, Regulatory knowledge (GCP, GVP, FDA 21 CFR Part 11/820, ISO 13485), Technology qualification (DHT, SaMD)
Preferred skills
Pharmaceutical development experience, M.Sc./Ph.D. in IT/Engineering/Science, Experience with AI/Medical devices in clinical trials, Cross-functional matrix leadership
Technologies
DHT, SaMD, SaaS, AI, Medical devices
Responsibilities
Provide technical QA SME support for Third-Party qualifications and governance; Identify risks for new Third Parties; Support clinical trial teams with technology fit-for-purpose assessments; Review and approve quality issues and escalate major/critical breaches; Facilitate 'Quality with Technology' discussions; Act as QA representative for Digital Technology initiatives; Ensure inspection readiness for outsourced activities.
Seniority
Senior, hands-on IC
