Associate Director, External Service Provider QA

Job Description Summary

As our Associate Director External Service Provider QA, you'll oversee the implementation of quality standards, processes, and tools. You will manage external service providers supporting Novartis Global Clinical Trials in R&D Quality, ensuring they meet high standards.

Job Description

Primary Location: London, United Kingdom

Secondary Location(s): Barcelona, Spain; Madrid, Spain; Dublin, Ireland

Working model: Hybrid (12 days/month in-office)

Key Responsibilities:

1. Review and approve ESP qualification for global trials.
2. Negotiate and execute QAA/quality terms with ESPs.
3. Review and approve QRAs to identify risks and issues proactively.
4. Manage quality issues, escalate major concerns, and support breach assessments.
5. Evaluate and review technology like SaMD, DHT, SaaS for compliance.
6. Support trial-specific technology assessments for study design fit.
7. Facilitate 'Quality with Technology' discussions to improve collaboration.
8. Represent ESPQA in digital and IT projects, managing Third-Party Quality activities.
9. Participate in technology reviews ensuring inspection readiness.
10. Ensure ESP activity readiness for audits and inspections.

Role Requirements:

Experience:

• 12+ years in pharmaceutical development.
• Knowledge of quality systems, clinical operations, and vendor management preferred.

Education:

• Bachelor's in Life Sciences, Pharmacy, Medicine, or related field.

Languages:

• Fluent in English (spoken & written).

Skills & Expertise:

• Knowledge of GCP/GLP, GMP, GVP.
• Leadership in quality systems and standards.
• Experience managing External Service Providers and knowledge of relevant standards.
• Technical understanding of quality systems and clinical trial processes.
• Experience with digital technology assessment and validation.
• Effective management of international collaborations.
• Strong root cause analysis, stakeholder engagement, and critical thinking skills.

Skills Desired:

• Auditing, Vendor Management, Quality Assurance, Risk Management, Stakeholder Management, and related skills.