Senior QA Lead for Tech-Driven Trials & Third-Party

(FCRS = US014) Novartis Pharmaceuticals Corporation; Barcelona; Hybrid; EUR 69,000 - 128,000; Full time

Job summary

Novartis Pharmaceuticals Corporation in Barcelona, Spain, seeks an Associate Director External Service Provider QA to liaise with clinical trial teams and Third Parties, providing expert QA support during due diligence, qualification and ongoing governance.

The role focuses on technology-enabled QA (DHT, SaMD, SaaS), audits, and ensuring data integrity and inspection readiness in a hybrid Barcelona-based setting.

Qualifications

• Extensive experience in pharmaceutical development and QA systems.
• Knowledge of quality management and regulatory standards.
• Experience with third-party management and inspections.

Responsibilities

• QA support for Third Party qualifications and governance oversight as a technical QA SME.
• Assist qualification and governance teams in identifying risks with new Third Parties.
• Support clinical trial teams for trial-specific assessments of technology.
• Review and approval of quality issues related to Third Parties and escalation of major issues.
• Lead Quality with Technology discussions with Third Party management and stakeholders.
• Act as QA representative for cross-functional Digital Technology initiatives.
• Participate in independent review of technology implementations for inspection readiness.

Skills

Auditing

Audit Management

Business Partnerships

Continuous Learning

Drug Development

Employee Performance Evaluations

Health Authorities (Inactive)

Influencing Skills

ISO 9001

Leadership

Organizational Savvy

People Management

Qa (Quality Assurance) (Inactive)

Quality Management

Quality Management Systems (QMS)

Risk Management

Root Cause Analysis (RCA)

Self-Awareness

Speed and Agility Training (Inactive)

Stakeholder Management

Technical Knowledge

Vendor Management

Education

Bachelor’s degree in Life Sciences, Pharmacy or Medicine, M. Sc. IT/Engineering/Scientific discipline and/or Ph.D. in a Scientific and/or Engineering discipline preferred

Job description

Novartis Pharmaceuticals Corporation in Barcelona, Spain, seeks an Associate Director External Service Provider QA to liaise with clinical trial teams and Third Parties, providing expert QA support during due diligence, qualification and ongoing governance.

The role focuses on technology-enabled QA (DHT, SaMD, SaaS), audits, and ensuring data integrity and inspection readiness in a hybrid Barcelona-based setting.