Associate Director, Tech QA for Third-Party Trials

IE02 (FCRS = IE002) Novartis Ireland Ltd; Dublin; Hybrid; EUR 73,000 - 135,000; Full time

Benefits offered by this job

Insurance plans

Retirement plans

Wellbeing resources

Global recognition programs

Flexible and hybrid working options

Minimum 14 weeks paid parental leave

Job summary

Novartis Ireland Ltd in Dublin is seeking an Associate Director External Service Provider QA to lead QA support for third-party qualifications and governance in a digitized trial environment.

The role requires expert QA knowledge across GxP, SaMD, and SaaS, with emphasis on risk monitoring, audits, and ensuring inspection readiness for health authorities. Hybrid working in Dublin is available.

Qualifications

• Extensive experience in pharmaceutical development and QA in vendor management.
• Bachelor's degree in Life Sciences, Pharmacy or Medicine; MSc/PhD preferred.
• Fluent English (spoken & written) and knowledge of GCP/GC LP, GVP, and medical device regs.

Responsibilities

• QA SME support for Third Party qualifications and governance oversight.
• Assist qualification and governance teams in identifying potential risks with new Third Parties (GxP).
• Support clinical trial teams for trial-specific assessments to ensure technology fits study design.
• Review and approve quality issues related to Third Party and escalate major issues.
• Support assessment of serious breach and reporting to health authorities.
• Facilitate 'Quality with Technology' discussions with Third Party management to address quality challenges.
• Act as QA representative for cross-functional Digital Technology initiatives and Third-Party Quality activities.
• Participate in independent review of technology implementations ensuring inspection readiness and data integrity awareness.
• Ensure inspection readiness of outsourced activities and support audits/HA inspections.

Skills

Auditing

Audit Management

Vendor Management

Quality Management

Quality Assurance

Risk Management

Root Cause Analysis

Stakeholder Management

Technical Knowledge

Leadership

Organizational Savvy

People Management

Documentation

Regulatory Compliance

Quality Management Systems

Education

Bachelor's degree in Life Sciences, Pharmacy or Medicine

MSc IT/Engineering/Scientific discipline

Ph.D. in Scientific/Engineering discipline

Job description

Novartis Ireland Ltd in Dublin is seeking an Associate Director External Service Provider QA to lead QA support for third-party qualifications and governance in a digitized trial environment.

The role requires expert QA knowledge across GxP, SaMD, and SaaS, with emphasis on risk monitoring, audits, and ensuring inspection readiness for health authorities. Hybrid working in Dublin is available.