Senior QA Lead, Third-Party & Digital Trials

ES06 (FCRS = ES006) Novartis Farmacéutica, S.A.

Sabadell

On-site

EUR 69,000 - 128,000

Full time

33 hours ago
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Benefits offered by this job

Insurance plans
Retirement plans
Wellbeing resources
Global recognition programs
Hybrid/flexible working
Parental leave

Job summary

Novartis is seeking an Associate Director External Service Provider QA to serve as the QA SME for Third Party qualifications, governance, and monitoring in a dynamic, technology‑driven clinical trial environment. This role collaborates with clinical teams and external partners to ensure quality and compliance across digital health and SaMD initiatives.

The position requires extensive GxP knowledge, vendor management experience, and strong English communication skills, with a base in Barcelona,

Qualifications

  • Extensive pharmaceutical development experience with QA expertise.
  • Strong knowledge of quality management systems and regulatory standards (GxP).
  • Experience with vendor management and third-party oversight.
  • Fluent in English; able to communicate across global teams.

Responsibilities

  • Provide QA SME support for Third Party qualifications and governance oversight.
  • Assist in risk monitoring and audits related to Third Parties.
  • Identify potential risks with new Third Parties for GxP use.
  • Support cross-functional trials to ensure technology fit for purpose.
  • Review quality issues related to Third Party activities and escalate as needed.
  • Support reporting to health authorities and inspection readiness.

Skills

QA experience
Quality systems
GxP knowledge
Vendor management
Cross-functional
English fluency

Education

Bachelor's Life Sciences
MSc IT/Engineering
PhD in Science/Engineering

Tools

SDLC
GxP systems

Job description

Novartis is seeking an Associate Director External Service Provider QA to serve as the QA SME for Third Party qualifications, governance, and monitoring in a dynamic, technology‑driven clinical trial environment. This role collaborates with clinical teams and external partners to ensure quality and compliance across digital health and SaMD initiatives.

The position requires extensive GxP knowledge, vendor management experience, and strong English communication skills, with a base in Barcelona,

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