QA Manager (d/f/m)

About the role

QA Manager (d/f/m), Kundl, Tyrol, Austria

Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Generic and Biosimilar medicines.

Now as an independently listed company, Sandoz aims to increase its strategic focus, operate with greater agility, set clearer business objectives, enhance shareholder returns, and strengthen its culture for us, the Sandoz associates. This is an exciting time in our history, and by creating a new and ambitious path, it will provide a unique opportunity for us all, both professionally and personally.

Join us as a Founder of our ‘new’ Sandoz!

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.

Role Requirements

What you’ll bring to the role:

Essential:
• 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.

Why Sandoz?

Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, touched the lives of almost 500 million patients last year and while we are proud of this achievement, we have an ambition to do more!

With investments in new development capabilities, state-of-the-art production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.

Our momentum and entrepreneurial spirit is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate 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:

#Sandoz

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.