Sep 19, 2022

Job Description

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. How would you like to be a key part of the Global Auditing at Novartis, building upon and maintaining our exceptional standards?

As Global GMP Senior Quality Auditor you will have the possibility to audit a great variety of GMP targets, including also high complex and novel technologies (biotechnologicals, radiopharmaceuticals, gene therapies, medical devices/combinational products, etc.)

You will lead, support and report independent GMP audits according to the Novartis Quality System and the current GMP regulations to assess compliance with applicable regulations, standards, and guidance documents. Review and approve corrective action plans in support of the audit observations. The audits performed include internal and external targets of manufacturing sites, development centers, quality systems, contract manufacturers, laboratories, warehouses, country organizations, and suppliers.

For this role, auditors will be given more complex and higher-risk audits: sterile API, Aseptic DP and combination products. The ability to assess risk of these operations is critical to success.

Your responsibilities include, but not limited to:

- Support the strategic development of an effective global risk-based audit strategy and program. Collect, collate, and incorporate input into the audit strategy and plan.
- Plan, lead, conduct, document, follow-up and reporting of GMP audit according to the requirements specified in the respective Novartis Quality procedures as well as applicable regulations, standards, quality agreements, and guidance documents.
- Provide regulatory guidance for timely remediation and recommendations regarding acceptability of the proposed filing.
- 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.
- Ensure adequate definition and recording of mitigation plans when applicable.
- Assess the adequacy of responses (CAPA plans) to audit findings in cooperation with the stakeholder QA representative and Auditee.
- Maintain, review and advise on relevant policies, procedures, regulations, standards, and guidance documents.

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:

• Education (minimum/desirable): Degree in Chemistry, Pharmacy, Biology, Engineering or another related science. Advanced degree preferred. Other degrees with relevant experience may be accepted.
• At least 12 years broad experience in Pharmaceutical or Medical Device Industry. The operational experience should include QA/QC management and manufacturing, or development or other relevant experience e.g. working at a regulatory health authority.
• Expertise in at least one of the following areas: DP Manufacturing, Laboratories activities, Medical Devices, API, Excipients, Sterile, Biologics, Microbiology, Computer System Validation, Packaging activities, Quality Systems.
• Experience and/or interaction with local Health Authority and sporadically with other Health Authorities.
• Strong interpersonal skills, including diplomacy and persuasion, used in obtaining cooperation and consensus with Novartis colleagues, vendors and customers.
• Sound and practical judgement in the interpretation and application of regulations and standards
• Ability to independently manage and objectively evaluate complex compliance issues with minimal supervision
• Must have/essential: Excellent knowledge of GMP regulatory requirements (US and European guidelines)

Desirable requirements:
• Languages: Excellent oral and written English communication skills. Preferable: Good knowledge/mother tongue of an additional language (e.g. German, French, Italian, Chinese, or Spanish) is a plus.
• 3 years auditing experience is preferred.

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.

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
Barcelona Gran Vía
Full Time
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Global GMP Senior Quality Auditor

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