348697BR
Jul 26, 2022
Austria

Job Description

AS&T Lead (f/m/d), Kundl, Austria

160 Million! This is the number of antibiotics packs that we produce in Kundl and deliver to patients in more than 80 countries all over the world in a year!

As AS&T Lead (m/f/d) you will be responsible for the leadership and development of associates, enabling the development, implementation, and control of the current good practices (cGxP)in the area of non-routine analytical activities in alignment with the local legislation (AMBO), EU directives and FDA guidelines.
You will provide conditions to enable smooth testing in manufacturing site(s) and participate in the process of ensuring regulatory compliance of the analytics' quality. You will be deeply involved in projects and continuous improvement initiatives happening at the site that support the growth pipeline of the Anti-Infectives Business.
Next to leadership, it is expected that you will actively participate in the department and overall Quality budgeting process, lead the department in a cost-efficient way, are implementing expert knowledge and skills and are involved in process optimizations.

Your key responsibilities:
• Ensuring all activities are in compliance with current good practice (cGxP) and all methods and procedures are up-to-date. Collaboration in GxP audits/inspections.
• Responsibility for maintenance and calibration of equipment, elaboration of the maintenance and calibration plan, product and process validations, supporting validation and qualification with analysis.
• Introducing new technologies; driving implementation of new requirements and improvement in Analytical Methods. Assisting respective laboratories in identifying opportunities for process optimization and continuous improvement.
• Supporting validation and qualification with analysis.
• Responsibility for the understanding of analytical methods and equipment within respective laboratories, and keeping up-to-date with the developments in analytics..
• Responsibility for the development, validation and administration of laboratory information systems and for the qualification of analytical equipment.
• Active representation within their respective unit, and participation at the global AS&T level for analytics.
• Driving the talent agenda: Leading people processes through recruitment, training, coaching and performance to meet all operation requirements and supporting career path deployment and succession plan for area of responsibility.

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:
• University degree in pharmacy, biology, chemistry, microbiology or other natural science degree.
• Minimum 8 years’ experience (preferably more) in Pharma/Manufacturing sector in analytical lab in a GMP environment on a leadership positions.
• Extensive leadership experiences, preferably at least 5 years or more.
• Extensive experiences within QC area and project management experiences.
• Extensive knowledge of regulatory affairs and Health authorities’ requirements.
• Fluent proficiency in English language (written and spoken).
• Great communication skills, as you will need to discuss with clients and regulatory affairs from different countries, good negotiations skills.
• Assertiveness.

Why Novartis?
769 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
Kundl
Quality
Full Time
Regular
No
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348697BR

AS&T Lead (m/f/d)

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