$ads={1}
QA Operations Lead – Sterile Forms (d/f/m), Kundl, Tyrol, Austria2023 will potentially see Sandoz become a standalone organization! Already a global market leader in Generics and Biosimilar medicine, this is an exciting, once-in-a-career opportunity to set our own path forward as an independent, purpose-driven organization, and as the founders of a new Sandoz, this is a time of immense opportunity for us all, both professionally and personally!
Together we will shape the future of Sandoz… are you ready to make a difference?
A QA Operations Lead is responsible to ensure compliance to cGxP standards for our product portfolio and for product release as well as to provide guidance, support and leadership to teams within the area of responsibility.
Your key responsibilities:
Your responsibilities include, but are not limited to:
- Leading the QA Operations group consisting of the units of Qualified Persons; QA Experts, QA Specialists and Aseptic Experts QA SAP Experts
- Driving the talent agenda: Leads people processes through recruitment, training, coaching and performance to meet all operational requirements and supports a robust career path deployment and succession plan for area of responsibility
- Assuring GMP compliance of batch manufacturing and taking usage decision for batches
- Providing operational and technical leadership for the QA Operations group in all quality and cGMP compliance related matters and ensure that all aspects of the operational business comply with cGMP legal and regulatory requirements and Novartis Sandoz Quality Manual requirements
- Participating as key function in operational site processes like approval of specifications, sampling instructions, test methods and other quality control procedures
- Ensuring the review of Batch Manufacturing Records and Batch Testing Records by groups of QA Specialists and Experts
- Performance and approval of investigations of major/critical deviations, OOS/OOE and complaints, CAPAs and Risk Assessments
- Representing QP group in evaluation of changes to processes and specifications and participation in the compilation and approval of validations, transfers and SOPs
- Preparation for and participation in audits and inspections
- Guide the QA Ops team in improving existing processes and procedures to further develop and maintain the quality system
Commitment to Diversity & Inclusion:
We are 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:
Essential:
Desirable requirements:
Why Sandoz?
Almost 500 million patients were touched by Sandoz generic and biosimilar medicines in 2022 and while we’re proud of this, we know there is more we could do to continue to help pioneer access to medicines for people around the world.
We are at a pivotal moment in our history giving us the freedom to invest in our future so we can continue to help millions of people access affordable high-quality medicines. Together we will shape the future of Sandoz, building an organization from the ground up and in return, experience an ambitious environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is encouraged!
The future is ours to shape!
Imagine what you could do here at Sandoz!
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. 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 € 80.433,64/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. We are open for part-time and job sharing models and support flexible and remote working where possible.
Join our Sandoz Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Sandoz and our career opportunities, join the Network here: https://talentnetwork.novartis.com/sandoztalentpool
#Sandoz
Essential:
- Advanced University or academic degree in chemistry, biology, pharmacy, engineering or equivalent
- Fluent (oral and written) in English, German desired
- Minimum of 5-7 years’ experience in an operational GxP area, in Manufacturing, Development or QA; with a thorough knowledge in aseptic filling operations and releasing medicinal products
- Profound experience leading large team in quality
- Ability to speak up and to take Quality decisions during challenging situations
- Strong leadership skills with excellent interpersonal, communication and negotiation abilities, with confirmed experience in change management and integration of teams and/or organizations
- Proven inspection track record with FDA, EMA, and other Health Authority inspections
- Passion for people coaching and development
Desirable requirements:
- Expertise in organization dynamics and culture, ability to gain trust and confidence at all levels in the organization, leadership, and project management experience
- Ability to work independently and effectively in international, complex, and multifaceted environments
Why Sandoz?
Almost 500 million patients were touched by Sandoz generic and biosimilar medicines in 2022 and while we’re proud of this, we know there is more we could do to continue to help pioneer access to medicines for people around the world.
We are at a pivotal moment in our history giving us the freedom to invest in our future so we can continue to help millions of people access affordable high-quality medicines. Together we will shape the future of Sandoz, building an organization from the ground up and in return, experience an ambitious environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is encouraged!
The future is ours to shape!
Imagine what you could do here at Sandoz!
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. 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 € 80.433,64/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. We are open for part-time and job sharing models and support flexible and remote working where possible.
Join our Sandoz Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Sandoz and our career opportunities, join the Network here: https://talentnetwork.novartis.com/sandoztalentpool
#Sandoz
Division
SANDOZ
Business Unit
Quality STO
Country
Austria
Work Location
Kundl
Company/Legal Entity
Sandoz GmbH
Functional Area
Quality
Job Type
Full Time
Employment Type
Regular
Shift Work
No
Early Talent
No
$ads={2}
