QA Operations Team Leader, Qualified person

Job Description Summary

#LI-Hybrid
Location: Kundl, Austria
This position is located in Kundl, Austria. Novartis cannot offer relocation support for this role: Please apply only if this location is accessible for you.
Imagine managing the QA Operations for the unique facility in Novartis network producing various nucleic acid products which are used in Novartis and external customer innovative medicines. In a dynamic environment, with your strong QA experience and as Qualified Person you will play a pivotal role in strategical projects for DS Kundl site as well as in driving the team performance to ensure fulfillment of site and external client targets.

 

Job Description

Your responsibilities include, but are not limited to:

• QA Operation activities execution according to cGxP standards in the area of responsibility. This includes:
• Leading the QA Operations Team for NAF in team culture in line with Novartis values and behaviors
• Oversight of all production & testing activities, ensures compliance with cGxP, incl. data integrity and eCompliance
• Oversee the technical transfer of processes and methods
• Continuous improvement fostering considering regulatory expectations and industry trends
• Product release as a “Qualified Person” or “Responsible Person” according to Austrian law (AMBO): Make release decisions for API, bulk and intermediate products in a timely manner incl. oversight of all records related to product manufacturing and testing

Minimum Requirements:

• Educational Background: Minimum master degree or equivalent in life sciences or equivalent discipline (bioengineering, pharmacy, medical, biology, chemistry, etc.) and fulfillment of the requirements to act as Qualified Person according to AMG §2 Abs 13b.
• Experience: Minimum of 5 years of relevant experience in quality control and/or analytical science & technology and in QA Operations, with proven cross-functional project management skills.
• Languages: Fluent in English and German
• Skills:  Strong communication, analytical, and problem-solving abilities. Ability to thrive in dynamic, fast-paced environments. Proven leadership with a collaborative, cross-functional approach. Skilled negotiator with excellent influencing, decision-making, and stakeholder engagement capabilities.

You’ll receive:

You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards

In addition to a market-competitive base salary, we offer an attractive incentive program, a modern company pension scheme, childcare facilities, learning and development opportunities as well as worldwide career possibilities 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 €78.383.90 /year (on a full-time basis). The actual salary will be significantly 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.

 

Skills Desired

Audit Management, Communication Skills, Continued Learning, Dealing With Ambiguity, Decision Making Skills, Employee Performance Evaluations, Gmp Procedures, Inspection Readiness, Organizational Skills, People Management, People Management and Leadership, Product Release, Qa (Quality Assurance), Self-Awareness, Technological Expertise