Associate Director, External Service Provider QA

Novartis; Dalkeith; Hybrid; GBP 80,000 - 120,000; Full time

Job summary

A leading company in the pharmaceutical industry is seeking an Associate Director for External Service Provider QA. The successful candidate will implement quality standards and manage external service providers for clinical trials. With a focus on compliance and excellence, this role requires extensive experience in pharmaceutical development and strong leadership skills.

Qualifications

• 12+ years in pharmaceutical development, strong knowledge of quality management.
• Experience in managing external service providers in clinical trials.
• Fluency in English and additional relevant expertise preferred.

Responsibilities

• Review and approve ESP qualifications for global clinical trials.
• Negotiate Quality Assurance Agreements with external service providers.
• Manage quality issues related to external service providers.

Skills

Leadership in quality systems

Stakeholder engagement

Root cause analysis

Knowledge of GCP/GLP, GMP, GVP

Education

Bachelor's degree in Life Sciences

Pharmacy

Medicine

Tools

IRT

eCOA

Imaging

Job description

Summary

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

About the Role

Primary Location: London, United Kingdom

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

Working model: Hybrid (12 days per month in the office)

Key Responsibilities:

1. Review and approve ESP qualification for global clinical trials.
2. Negotiate and execute Quality Assurance Agreements with ESPs.
3. Review and approve QRAs to identify risks and issues proactively.
4. Manage quality issues related to ESPs and escalate critical issues; support breach assessments and reporting.
5. Evaluate and assess technology like SaMD, DHT, SaaS for regulatory compliance.
6. Support trial-specific technology assessments to ensure fit for purpose.
7. Facilitate 'Quality with Technology' discussions to enhance understanding and collaboration.
8. Represent ESPQA in digital and IT projects, managing third-party quality activities.
9. Participate in technology implementation reviews for inspection readiness.
10. Ensure inspection readiness and support audits and inspections related to ESPs.

Role Requirements:

Experience: 12+ years in pharmaceutical development; knowledge of quality management, clinical operations, and vendor management preferred.

Education: Bachelor's degree in Life Sciences, Pharmacy, Medicine, or related field.

Languages: Fluent in English.

Skills & Expertise: Knowledge of GCP/GLP, GMP, GVP; leadership in quality systems; experience managing ESPs; familiarity with IRT, eCOA, Imaging; understanding of quality systems, clinical trials, and digital validation; stakeholder engagement and root cause analysis skills.

Why Novartis:

Join us to help people with diseases, collaborate with passionate colleagues, and achieve breakthroughs that change lives. Learn more: https://www.novartis.com/about/strategy/people-and-culture

Join our Novartis Network:

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Benefits and Rewards:

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