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hace 2 semanas
766 766 million patients reached in 2021, Billion treatments supplied, 21 major approvals in US, EU, Japan and China and 3 breakthrough therapy designations by FDA only in 2021. Would you also like to be a key part of the Global Auditing at Novartis, building upon and maintaining our exceptional standards?
We are looking for outstanding professionals with experience as GCP/PV Auditor with a passion for quality with a patient focus. As GCP/PV Senior Auditor in Novartis, you will manage cost effective GxP Compliance and/or Audit activities, operations and systems to ensure compliance of business areas with the Novartis Quality Manual and Policies and all relevant GxP, legal and regulatory requirements, and through internal audits, KPIs (Key Performance Indicators) and KQIs (Key Quality Indicators).
**We welcome amazing talent across Spain**
**Your responsibilities include, but are not limited to**:
- Lead, plan, conduct, document and follow-up of global quality regulatory compliance audits and assessments of GCP/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.
- 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)..
- Mentor junior GCP/PV staff as required.
**Commitment to Diversity & Inclusion**:
- We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._
**Minimum requirements**
**What you’ll bring to the role**:
- 10 years of GCP/PV/Pharmaceutical Industry/Health Authority experience or equivalent.
- At least 3 years of GCP/PV auditing experience; experienced in both PV and GCP auditing is ideal.
- Ability to independently manage and objectively evaluate complex compliance issues with mínimal supervision.
- Flexibility and willingness to travel up to 60%.
- Experience dealing with Health Authority inspections is a plus.
- Strong knowledge of GCP, GVP, GxP regulations.
- Fluency in English is essential - written and spoken. Additional languages are welcome.
**Do not you possess the level of seniority now, but you have a strong desire and agility to learn?**
Send us your CV anyway, and support it with a cover letter outlining your purpose and aspirations.
**You will receive**:
Competitive salary, annual bonus, company pension plan, health insurance, life and accidental insurance, flexible working arrangements, subsidized dining facilities, employee recognition scheme.
**Why consider Novartis?**
766 million lives were touched by Novartis medicines in 2021, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying
Imagine what you could do here at Novartis
**Division**
Operations
**Business Unit**
QUALITY
**Country**
Spain
**Work Location**
Barcelona
**Company/Legal Entity**
Novartis Farmacéutica, S.A.
**Alternative Country 1**
Poland
**Functional Area**
Quality
**Job Type**
Full Time
**Employment Type**
Regular
**Shift Work**
No
**Early Talent**
No
