Senior Global GCP/PV Auditor

Healthcare Businesswomen’s Association; A distancia; EUR 50.000 - 70.000; Jornada completa

Descripción de la vacante

A leading healthcare organization is seeking a professional to lead and support GCP/PV audits while ensuring compliance with regulations. The successful candidate will manage independent audits and provide leadership to a team. With over 7 years of experience in the pharmaceutical industry and knowledge of regulatory standards, you'd contribute significantly to maintaining quality assurance. This role offers a full remote job with the possibility to work from either Barcelona or Madrid, and requires up to 60% travel.

Formación

• 7+ years of GCP and PV experience, including 3 years of auditing.
• Ability to manage and evaluate compliance issues independently.
• Extensive knowledge of GCP/PV regulations and guidelines.

Responsabilidades

• Lead global quality regulatory compliance audits.
• Prepare audit reports according to requirements.
• Provide technical guidance and training to auditors.

Conocimientos

GCP and PV auditing

Compliance evaluation

Risk-based audit strategy

Technical guidance and mentoring

Project management

Educación

Degree in natural/biological sciences

Advanced degree (desirable)

Descripción del empleo

Job Description 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. You will review and approve corrective action plans in support of the audit observations, ensuring alignment with the strategic direction of the company and assist in driving implementation of the applicable actions.

Job Description

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 GCP/PV 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). Advanced 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: 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.