Summary
In this role you will lead, support and report independent GCP/PV audits according to the NVS Quality System and the current GCP/PV regulations to assess compliance with applicable regulations, standards, and guidance documents. In this role you will review and approve corrective action plans in support of the audit observations, ensuring alignment with strategic direction of the company and assist in driving imple-mentation of the applicable actions.
About The Role
In this role you will be required to travel up to 60% of time.
This is a full remote job with flexible location (Barcelona or Madrid).
Major Accountabilities
* Support the strategic development of an effective global risk-based audit strategy and programme; collect, collate and incorporate input into audit strategy and plan.
* Lead, plan, conduct, document and follow-up of global quality regulatory compliance audits and assessments of GPvP according to the requirements specified in the respective Novartis Quality Module as well as applicable regulations, standards, quality agreements, and guidance documents. Perform activities with a high degree of independence.
* Provide technical guidance, leadership, mentoring and training of other auditors on audit related activities.
* Prepare audit reports according to NVS requirements and timelines.
* Ensure appropriate escalation to responsible management in case of critical findings and support immediate follow-up measures according to NVS requirements on Management Escalations and other relevant procedures.
* Assess the adequacy of responses (CAPA plans) to audit findings in cooperation with Follow-up Responsible Person (FURP) and Quality Responsible Person (QARP).
* Identify and communicate quality and regulatory compliance issues to Quality Management through appropriate channels as well as recommend remediation.
* Lead compliance investigations and initiatives focused on inspection readiness and quality, process and compliance improvement as requested.
* Support Mock Pre-Approval Inspections (PAIs) and Health Authority (HA) inspections as needed.
Minimum Requirements
* Education: degree in natural/biological sciences or equivalent (or an equivalent mix of education and experience). Advance degree desirable.
* 7+ years of GCP and PV/Pharmaceutical Industry/Health Authority experience or equivalent up of which 3 years of GCP or PV auditing experience (or both).
* Ability to independently manage and objectively evaluate complex compliance issues with minimal supervision.
* Ability to address a variety of tasks within the same timeframe while maintaining oversight; ability to maintain a high degree of independence with respect to decision making and problem solving.
* Experience with Health Authority inspections and interaction;
* Extensive knowledge of applicable GCP / PV and GxP regulations, guidelines, policies and procedures.
* Good knowledge of computer systems validation and 21CFR Part 11 requirements.
Desirable Requirements
* Auditor certification would be highly valued.
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:
You'll receive:
You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. 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:
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?
Benefits and Rewards:
Learn about all the ways we'll help you thrive personally and professionally.
Read our handbook (PDF 30 MB)