Associate Director ESP Quality

Location: London (The Westworks)

Salary Range

£63,917.00 - £118,703.00

Job Description Summary

#LI-Hybrid

Location: London, UK

This role is based in London, UK. Novartis is unable to offer relocation support for this role. Please only apply if this location is accessible for you.

As Associate Director External Service Provider QA, you will have an excellent opportunity to work as a liaison with the Novartis clinical trial teams and Third Parties to provide expert QA support during the Third-Party due diligence, qualification and on-going governance and monitoring.

The use of various types of technology (i.e., DHTs, Medical devices, AI) continues to evolve for use in clinical trials. As such, the approach to qualification and oversight continues to evolve and change, requiring adaptive approaches and specialized skills.

Key Responsibilities

QA support for technology-enabled (DHT, SaMD, SaaS) Third Party qualifications and governance oversight as a technical QA SME in the evolving digital and innovation landscape. This includes the initial qualification, routine risk monitoring and SME support during audits.

Assist qualification and governance teams in identifying potential risks with new Third Parties, whether for GxP purposes or rapid ramp-up from exploratory to GxP use.

As and when needed support the clinical trial team for trial specific assessment to ensure technology is fit for purpose based on specific study design.

Responsible for review and approval of quality issues related to Third Party and ensure appropriate escalation of major and critical issues. Support assessment of serious breach and reporting to health authorities.

Facilitate the ‘Quality with Technology’ discussions with Third Party management team other interested parties to promote greater understanding of quality challenges when working with tech enabled Third Parties and overcome them through improved collaboration and awareness

Act as QA representative for cross-functional Digital Technology initiatives, managing the overall Third-Party Quality activities.

Participate in the independent review of technology implementations ensuring inspection readiness and data integrity awareness.

Ensure inspection readiness of outsourced related activities and support for internal and external audits and health authority (HA) inspections pertaining Third Party management.

Minimum Requirements

• Extensive experience in pharmaceutical development and excellent knowledge of the quality management system, clinical operations processes and vendor management related activities is preferred.
• Minimum a 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.
• Fluent English (both spoken & written)
• Working knowledge of GCP/GcLP, GVP, Medical Device regulations.
• Experience with clinical third-party management.
• Combination of computer system compliance and validation expertise associated with global IT systems development (SDLC) and implementation within the pharmaceutical and/or digital health technology (DHT).
• Broad knowledge of regulations and industry quality standards (GCP, ICH, FDA 21 CFR Part 11, FDA 21 CFR 820, ISO 13485).
• Expertise in implementing DHT/SAMD technology within innovative clinical trials preferred.
• Experience navigating complex problems and developing solutions within a matrixed environment.
• Demonstrated ability to partake in interdisciplinary projects with a wide range of business functions and successfully work in a global cross-functional matrix.