Senior QA Operations Expert; Qualified Person (m/f/d)

Job Description Summary

#LI-Hybrid

Location: Schaftenau, Austria

The Qualified Person (QP / Sachkundige Person) is responsible for the final certification and release of medicinal products in accordance with § 7 of the Arzneimittelbetriebsordnung (AMBO 2009).
Based in Austria, you will ensure that every batch is manufactured and tested in full compliance with the Austrian Medicines Act (AMG), the Marketing Authorization, and current GMP requirements. With clear legal accountability, you will verify product quality and documentation to ensure no batch is released—whether for the Austrian market or for export—without confirmed compliance.

 

Job Description

Key responsibilities: ​

Essential Requirements:

Novartis Austria is one of the most modern and innovative manufacturing sites in the Novartis network. The sites in Tirol have approximately 3,500 employees and there are approximately 350 employees in the marketing & sales office in Vienna. 
The site in Tirol is in the middle of the Austrian Alps with excellent infrastructure.

Benefits & Rewards :

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 € 73.122,90/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 and Inclusion:

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Accessibility and Accommodation:

If because of a medical condition, physical disability or a neurodiverse condition you require an adjustment during the recruitment process, please reach out to disabilities.austria@novartis.com and let us know the nature of your request as well as your contact information. The support which we can provide will include advice on suitable positions as well as guidance at all stages of the application process. Austrian law provides candidates the opportunity to involve the local disability representative, Behindertenvertrauensperson (BVP), in the application process. If you would like to request this, please let us know in advance as a note on your CV.

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Major Accountabilities:

• Critical Negotiations, People Leadership, Operations Management and Execution, Collaborating across boundaries, Project Management  
• Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt
• Distribution of marketing samples (where applicable)

Key performance indicators:

• Successful support of projects with agreed quality & delivery dates, passing of internal and external inspections.
• Meet quality & timelines for all projects.
• Act in accordance with GMP, ethical, health safety and environment (HSE), and information security (ISEC).
• The number and severity of cGMP issues identified during internal and external audits.
• Year-end figures within budget.

Minimum Requirements:
Work Experience:

• Audit & Inspection Management.
• Good Manufacturing Practices (cGMP).
• Release Management.
• Quality Management Systems.
• Technical Operations.
• GxP Experience.
• People Management.
• Quality Assurance.
• Quality Compliance.
• Technological Expertise.
• Patient Safety.

Skills:

• Collaboration.
• Regulatory requirements knowledge.
• Dealing with ambiguity.
• Problem Solving Skills.
• Communication skills.
• Data Integrity.
• Digital saviness.
• Leadership.
• Decision Making.

Languages :

• English.

 

Skills Desired

Collaboration, Communication Skills, Data Integrity, Dealing With Ambiguity, Decision Making, Digital saviness, Leadership, Problem Solving Skills, Regulatory Requirements knowledge