QA Manager (d/f/m), Kundl, Tyrol, Austria
2023 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?
This position ensures all aspects of manufacturing, testing, release and distribution for bio-logics and/or sterile pharmaceutical products at external supplier sites comply with international standards of current Good Manufacturing Practice (cGMP), regulatory requirements, the Sandoz Quality Manual, and the applicable Quality Agreements.
Your key responsibilities:
Your responsibilities include, but are not limited to:
• Acts as Single Point of Contact / SPOC for all quality related activities at assigned external suppliers.
• Supplier qualification: Ensures a valid Quality Agreement in line with the requirements of the Sandoz global template is in place and continuously amended to the business needs.
• Routine monitoring: Assesses quality trends and drives continuous improvement including stability reports and annual product quality reviews.
• Incident management: Manages all quality issues (complaints, deviations, OOX).
• Change controls: Ensures that change requests, either from the external supplier or from Sandoz, are managed appropriately from receipt, through to the implementation and closure.
• Manufacturing process and analytical methods transfers: Ensures QA Oversight during commercial product transfers.
Diversity & Inclusion / EEO
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
What you'll bring to the role:
• Bachelor or higher in Biochemistry, Chemistry, Microbiology or anoth-er related science
• Fluent in speaking / writing in English
• Min 5 years of experience in in the pharmaceutical industry. Min 3 years of experience in the manufacturing of sterile pharmaceuticals. Basic knowledge in aseptic/sterile pharmaceutical processes and manufacturing of biologics.
• Min 3 years of experience in operational quality assurance. Advanced knowledge of cGMP requirements for major regulated markets (EU, US). Basic experience with FDA, EMEA and other Health Authorities. Advanced understanding of risk management. Basic understanding of project management.
• Advanced communication and basic negations skills. Basic decision-making ability skills.
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 €60,212.18/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. 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