Primary Location: London, United Kingdom

Secondary Location(s): Barcelona, Spain or Dublin, Ireland

Working model:  All locations have a hybrid working model

Key Responsibilities:  

• QA/Compliance 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 suppliers, whether for GxP purposes or rapid ramp-up from exploratory to GxP use.
• 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 ESPs 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 ESP related activities and support for internal and external audits and health authority (HA) inspections pertaining ESP management.

Role Requirements:

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, M. Sc. IT/Engineering/Scientific discipline and/or Ph.D. in a Scientific and/or Engineering discipline preferred.

Languages:

• Fluent English (both spoken & written)

Skills & Expertise:

• Working knowledge of GCP/GcLP, GVP, Medical Device regulations.
• Experience with third-party qualification and/or auditing.
• Combination of computer system compliance and validation expertise associated with global IT systems development (SDLC) and implementation within the pharmaceutical and/or medical device industry.
• 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.

Accessibility and accommodation  

Novartis is committed to working with and providing reasonable accommodation to all individuals. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to receive more detailed information about the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.