Head GxP Compliance and Health Authorities Inspection Support

Summary

As Head GxP Compliance and HA Inspection Support you will ensure GxP compliance across Novartis, in alignment to evolving regulatory landscape. You will also ensure availability of required tools and training materials to support preparation for Health Authority Inspections and audits and support Compliance Platform and Function Leaders in the implementation of GxP compliance strategy across Novartis.
In this role you will also support the establishment of a comprehensive GxP compliance framework for the application of Artificial Intelligence (AI) within Novartis. This includes monitoring the AI regulatory landscape and requirements, proactively identifying and mitigating any associated compliance risks within Novartis.

About the Role

Major accountabilities:

• Provide support and training to ensure inspection readiness before and during strategic Health Authority Inspections and audits. Support review of response to HAI observations. Ensure remediation activities are undertaken, implemented, and the effectiveness verified at the respective sites and entities.
• Actively contribute to the Gen AI governance and initiatives. Support building a robust GxP eCompliance framework for application of Artificial Intelligence (AI) within Novartis, using GenAI tools.
• Participate in Global Aseptics and ATMP Expert Network and support reinforcing fundamental prerequisites of the aseptic area training, and practices.
• Actively participate in the category 2/3 escalation meetings as required, provide investigation support for any potential GMP gaps that may result in material impact to Novartis.
• Contribute on the development and deployment of strategic Quality/Compliance related projects including QMS, risk management and Data integrity.
• Liaise with RA Policy team on Regulatory intelligence, emerging guidances including identifying any draft guidance documents for commenting. Assist QMS team to review final guidance documents issued by the HA for gap assessment through the publication of Regulatory Newsflash on monthly basis.
• Support QMS related activities and actively contribute/participate in the QMS governance and network meetings.
• Ensure all applicable SOPs are routinely monitored for updates for the processes owned in line with attached role profile (See attachment 1).
• Support the Quality Systems Programs and other internal compliance initiatives including Novartis Engagement with Industry Forum activities, and projects related topics.

Minimum Requirements:

• Education: Undergraduate Degree in a science discipline; additional knowledge in Pharmaceutical Manufacturing technology and practices; Quality Assurance/ Compliance and Auditing; graduate degree desired.
• Minimum of 15 years experience in the pharmaceutical or biopharmaceutical industry in Operation and QA roles. Significant experience in either operations or QA roles supporting sterile operations and/or ATMPs is required.
• Demonstrated ability to execute detailed and complex investigations, including detection of potential data integrity breaches.
• Knowledge and experience related to eCompliance Regulations and an interest in the developing GenAI landscape.
• Prior exposure to HA inspections / auditing experience required (min. 5 years).
• Strong oral and written communication, social and organizational skills required.
• Availability for min. 25 % travel on a global basis.
• Fluent English, written and spoken, other languages are a plus.

Why Novartis? Our purpose is to reimagine medicine to improve and extend people's lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture

You'll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards Commitment to Diversity and Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

Benefits and rewards: Read our handbook to learn about all the ways we'll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards

Commitment to Diversity and Inclusion:

Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

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? https://www.novartis.com/about/strategy/people-and-culture

Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network

Benefits and Rewards: Read our handbook to learn about all the ways we'll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards

Division
Operations

Business Unit
Innovative Medicines

Location
Spain

Site
Barcelona Gran Vía

Company / Legal Entity
ES06 (FCRS = ES006) Novartis Farmacéutica, S.A.

Alternative Location 1
Hyderabad (Office), India

Alternative Location 2
Ljubljana, Slovenia

Functional Area
Quality

Job Type
Full time

Employment Type
Regular

Shift Work
No