Associate Director ESP Quality

Overview

In this role, you will serve as the QA SME for technology-enabled third-party qualifications and governance in clinical trials. You’ll liaise with trial teams and external partners to ensure quality across DHTs, SaMD, SaaS and related processes within a rapidly evolving digital landscape. You will drive risk monitoring, audits, and escalation of critical issues, shaping compliant use of tech in trials. This position offers impact through cross-functional collaboration and a clear focus on data integrity and inspection readiness.

Pay / Benefits

• flexible and hybrid working options
• minimum 14 weeks paid parental leave
• insurance plans
• retirement plans
• wellbeing resources
• global recognition programs

Responsibilities

• Lead QA support for third-party qualification and governance of tech-enabled solutions (DHT, SaMD, SaaS)
• Identify and assess risks with new third parties for GxP and rapid ramp-up
• Support trial-specific assessments to ensure tech fit-for-purpose per study design
• Review and approve quality issues and escalate major/critical findings
• Facilitate Quality with Technology discussions with third-party teams to improve collaboration
• Act as QA representative for cross-functional Digital Technology initiatives
• Participate in independent reviews of technology implementations for inspection readiness and data integrity
• Ensure inspection readiness of outsourced activities and support HA inspections

Key requirements

• Extensive experience in pharmaceutical development and strong knowledge of QMS, clinical operations, and vendor management
• Bachelor’s degree in Life Sciences, Pharmacy or Medicine; MSc IT/Engineering/Scientific discipline or PhD preferred
• Fluent English (spoken and written)
• Working knowledge of GCP/GcLP, GVP, Medical Device regulations
• Experience with clinical third-party management
• Experience with computer system compliance and validation (SDLC) in pharma or digital health technology
• Knowledge of GCP, ICH, FDA 21 CFR Part 11, FDA 21 CFR 820, ISO 13485
• Experience implementing DHT/SaMD in clinical trials
• Ability to navigate a matrixed, cross-functional organization
• Strong interdisciplinary collaboration skills

• Stakeholder management
• Leadership
• Organizational savvy
• GCP/GcLP
• GVP
• Medical Device regulations

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