Associate Director (AD), External Service Provider Quality Assurance (ESPQA)

Overview

This is a temporary contractor opportunity at Novartis. Novartis touches the lives of a tenth of the world's population. Every role here, regardless of contract type, makes an impact on human life!

Novartis partners with external managed service provider Magnit Global to offer engaging temporary contractor opportunities like this, to those who are looking for flexibility in their career while gaining new skills and experiences providing services to an inclusive global medicines company. Ready to work with Magnit at Novartis? Please read on

About this role

As our AD External Service Provider QA, you will have the opportunity to manage quality oversight for Development (Clinical, PV, GLP) external service providers for Development. You will play a pivotal role in managing external service providers supporting Global Clinical Trials in R&D Quality, ensuring that our partners meet the highest standards of excellence.

Key Responsibilities

• Responsible for review and approval of External Service Providers (ESPs) qualification for global clinical trials and Medical affairs studies (RCs, PASS, NIS etc).
• Responsible for negotiation and execution Quality Assurance Agreements (QAA) / quality terms with ESPs.
• Review and approval of external service provider Quality Risk Assessments (QRAs) to enable identification and evaluation of metrics, risks, trends, and potential quality and performance issues with the ESP in a proactive manner. Ensure communication and support mitigation of actions for potential risks.
• Responsible for review and approval of quality issues related to ESPs and ensure appropriate escalation of major and critical issues. Support assessment of serious breach and reporting to health authorities.
• Collaboration with business partners such as Global Medical Affairs, Vendor Partnership and Governance, Study Startup Organisation, Country Development Quality and Procurement to ensure their involvement in the risk evaluation and timely communication to the business and follow-up on required actions.
• Review quality metrics, monitoring and reporting including follow-up with line functions and escalation.
• Ensure inspection readiness of local ESP related activities and support for internal and external audits and health authority (HA) inspections pertaining to local ESP management.
• Ensure compliance with regulatory requirements (GCP, GLP, GVP, GMP) and continuous improvement of quality relevant processes within area of responsibility.

Experience

• 12+ years' experience in pharmaceutical development and excellent knowledge of the quality management system, clinical operations processes and vendor management related activities is preferred.

Education

• Minimum a bachelor's degree in Life Sciences, Pharmacy or Medicine, or other related discipline required

Languages

• Fluent English (both spoken & written)

Workload

7 hours per day

Role type

Onsite

Required start date

1 June 2026

Contract

18 months

Why Novartis

Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together?

EEO Statement

The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.

Accommodation

If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to Magnit at .