348198BR
Aug 01, 2022
Austria

Job Description

25! This is the number of Novartis production sites that our Austrian External Supplier Organization (ESO) Team supports all over the globe. Being part of the ESO team you will be working in a very international team with a lot of global interaction and attractive tasks.

The position ensures all aspects of manufacturing, testing, release and distribution for key biologics and/or sterile pharmaceutical products at strategic external supplier sites in compliance with international standards of current Good Manufacturing Practice (cGMP), regulatory requirements, the Novartis Group Quality Manual, and the applicable Quality Agreements.

Your key responsibilities:
• Acting as Single Point of Contact for all quality related activities at assigned external suppliers. Providing the quality presence and input to technical meetings with the external suppliers.
• Ensuring a valid Quality Agreement in line with the requirements of the Novartis global template is in place and continuously amended to the business needs.
• Ensuring current external supplier quality risk assessments are in place and appropriate actions are taken to mitigate potential risks.
• Ensuring site readiness for regulatory inspections and quality audits and supports during such events.
• Assessing quality trends and driving continuous improvement including stability reports and annual product quality reviews. Critically assessing the performance of the product and process performed at the external supplier.
• Managing all quality issues (complaints, deviations, OOX). Ensuring investigations are correctly executed and all required actions are taken appropriately and in a timely fashion.
• Ensuring that change requests, either from the external supplier or from Novartis, are managed appropriately from receipt, through to the implementation and closure.
• Ensuring QA Oversight during commercial product transfers. Assessing validation readiness. Ensuring knowledge transfer for stable commercial manufacturing operations. Supporting the establishment of continuous process verification programs.

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:
• Bachelor or higher in Biochemistry, Chemistry, Microbiology or another related science.
• Min 8 years of experience in in the pharmaceutical industry. Min 5 years of experience in the manufacturing of sterile pharmaceuticals. Expert knowledge in aseptic/sterile pharmaceutical processes and manufacturing of biologics.
• Min 5 years of experience in operational quality assurance. Expert knowledge of cGMP requirements for major regulated markets (EU, US). Advanced experience with FDA, EMEA and other Health Authorities. Expert in risk management. Advanced understanding of project management.
• Expert in communication and advanced negations skills. Advanced decision-making skills.
• Fluent in English language (written and spoken).
• Flexibility to work in a fast paced, quickly changing work environment.
• Ability to operate in a global matrix environment.

Desirable Requirements:
• Desirable supplier management experiences.

Why Novartis?
750 million lives were touched by Novartis medicines in 2020, 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!

In addition to a market-competitive base salary, we offer an attractive incentive program, a modern company pension scheme, childcare facilities, learning and development options as well as worldwide career opportunities within the Novartis group. In accordance with Austrian law, we are obliged to disclose the minimum salary as stated in the collective bargaining agreement. For this position the minimum salary is € 66.526,88/year (on a full time basis). In most cases, the actual salary will be higher, as we strive to maintain a competitive position in the market and consider your previous experience, qualifications and individual competencies.


Commitment to Diversity & Inclusion:

Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.
Our recruitment decisions are based on selecting the best person for the job, regardless of gender, religion, age, colour, race, sexual orientation, nationality or disability.

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
Novartis Technical Operations
NTO QUALITY
Austria
Schaftenau
Quality
Full Time
Regular
No
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348198BR

Senior Quality Assurance Manager (m/f/d)

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