Associate Director ESP Quality

About the role

Novartis is hiring an Associate Director External Service Provider QA in Barcelona, Spain, to act as a liaison between its clinical trial teams and third parties. You will provide expert quality assurance support during third-party due diligence, qualification and ongoing governance and monitoring. The role covers technology-enabled third parties such as DHTs, medical devices and AI, and is listed as hybrid.

Key responsibilities

• Provide QA support for technology-enabled third-party qualifications and governance oversight, including initial qualification, routine risk monitoring and audit support
• Help qualification and governance teams identify risks with new third parties, for GxP purposes or rapid ramp-up from exploratory to GxP use
• Support the clinical trial team in assessing whether technology is fit for purpose for each study design
• Review and approve quality issues related to third parties, escalate major and critical issues, and support assessment of serious breaches and reporting to health authorities
• Facilitate quality discussions with third-party management to improve collaboration on quality challenges
• Act as QA representative for cross-functional digital technology initiatives, managing overall third-party quality activities
• Take part in independent reviews of technology implementations, ensure inspection readiness and support internal and external audits and health authority inspections

Required profile

• Bachelor's degree in Life Sciences, Pharmacy or Medicine, or M.Sc./Ph.D. in a scientific or engineering discipline preferred
• Fluent English, spoken and written
• Experience with clinical third-party management
• Experience navigating complex problems in a matrixed environment and working in global cross-functional projects
• Preferred: extensive experience in pharmaceutical development and vendor management

Required skills

• Working knowledge of GCP/GcLP, GVP and medical device regulations
• Knowledge of GCP, ICH, FDA 21 CFR Part 11, FDA 21 CFR 820 and ISO 13485
• Computer system compliance and validation expertise (SDLC) in pharmaceutical and digital health technology
• Preferred: expertise implementing DHT/SaMD technology in clinical trials

What we offer

• Base salary range of 69,100 to 128,300 EUR, with a possible performance-based bonus
• Flexible and hybrid working options where possible
• Insurance plans, retirement plans, wellbeing resources and global recognition programs
• Minimum 14 weeks of paid parental leave