Apr 14, 2022

Job Description

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 candidates with experience as GCP/PV/CSV auditor with a passionate for quality with a patient focus. As GCP/PV Expert Auditor you have strong understanding of the challenges and requirements of clinical development, strategically minded to impact the direction of future audits.

We pursue amazing talent across Spain!
This position comes with a flexible location and we are ready to hire this role in the city of preference (within Spain) of the successful candidate.

As GCP/PV Expert Auditor you will lead, support and report independent GCP/PV audits according to the Novartis Quality System and the current GCP/PV regulations to assess compliance with applicable regula-tions, standards, and guidance documents.

Your responsibilities include, but not limited to:

- Contribute to establishing the strategic direction of an effective global risk-based audit strategy and program. Collect, collate, and incorporate input into the audit strate-gy and plan.
- Plan, lead, conduct, document, and follow-up of GCP/PV audit according to the requirements specified in the respective Novartis Quality Module as well as applicable regulations, standards, quality agreements, and guidance documents.
- For this expert role, the leader in this position is able to audit complex and high-risk sites and activities. You are an expert and SME and will perform pre-approval/pre-submission project reviews, “mock” pre-approval in-spections across GDD and/or external entities in accordance with the standards de-fined in the Novartis Quality Manual, the Novartis Audit Manual, and nation-al/international GxP requirements.
- Provide technical guidance, mentoring, and training on audit activities.
- Ensure appropriate escalation to responsible management in case of critical observations and support immediate follow-up measures according to Novartis re-quirements on Management Escalations and other relevant procedures. Ensure adequate definition and recording of mitigation plans when applicable.
- Assess the adequacy of responses (CAPA plans) to audit findings in cooperation with the Follow-up Responsible Person (FURP) and Auditee (Quality Responsible Person, QARP).
- Act as GCP/PV compliance consultant for GCP/PV trainings, task forces, continuous improvement projects as needed.
- Review and advise on relevant policies and procedures.
- Mentor junior GCP/PV staff as required. Ability to perform training for non-certified and junior GCP/PV staff
- Support HA commitments and global commitments/initiatives as an outcome of inspection findings.

Diversity & Inclusion / EEO

Novartis is 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:

- Degree in natural/biological sciences or equivalent (or an equivalent mix of education and experience). Advance degree desirable
- English fluency at operational and functional level (as first or second language; second language is preferred)
- 12+ years GxP experience in Pharmaceutical Industry/Health Authority experience or equivalent;
- 5 years of GCP/PV auditing experience; including preferably auditor certification by an industry recognized body (e.g. ASQ) and excellent knowledge of regulatory requirements.
- Willingness to travel approximately 60% of the time;
- Experience and/or interaction with local Health Authority and sporadically with other Health Authorities.
- Excellent interpersonal skills, including diplomacy and persuasion, used in obtaining cooperation and consensus with Novartis colleagues, vendors and customers. The Associate must be able to effectively represent the department both internally and externally.
- Ability to independently manage and objectively evaluate complex compliance issues with minimal supervision
- Good knowledge of computer systems validation and 21CFR Part 11 requirements

Do not you possess the level of seniority now, but do 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’ll receive:

Competitive salary, annual bonus, pension scheme, health insurance, flexible working arrangements, subsidized dining facilities, employee recognition scheme.

Why consider Novartis?

769 million. That’s how many lives our products touched in 2020. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?

We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.

Imagine what you could do at Novartis!

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
Novartis Technical Operations
Full Time
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GCP/PV Expert Auditor

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