Senior Quality Assurance Manager (d/w/m), ESO Biosimilars, Kundl, Austria

Job Description Summary

Senior Quality Assurance Manager (d/w/m), ESO Biosimilars, Kundl, Austria

Job Description

Senior Quality Assurance Manager (d/w/m), ESO Biosimilars, Kundl, Austria

Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines. By creating a new and ambitious path, it will provide a unique opportunity for us all, both professionally and personally. Join us, the future is ours to shape!

As Senior QA Manager ESO Biosimilars, you will be responsible for managing quality aspects at external suppliers to ensure that the operational business is in compliance with cGMP (Current Good Manufacturing Practices), the Quality Assurance Agreement, regulatory requirements and the Sandoz Quality Manual and is conducted according to the relevant Standard Operating Procedures.

Your Key Responsibilities:

Your responsibilities include, but not limited to:

• Acts as Single Point of Contact / SPOC for all quality related activities at the External Supplier and establishing good working relationships with clear communication and defined actions and goals.
• Negotiation of Quality Assurance Agreements (QAA) with external partners.
• Change and deviation management, complaint handling.
• Escalate risks and issues, as well as propose mitigating actions.
• Responsibility for ensuring timely achievement of project Quality deliverables.
• Contribute to process simplification and QMS improvements
• Responsible for the conduct of internal and external audits of the quality system (approval of suppliers, contract suppliers and contract manufacture suppliers).
• Stability reports and PQR’ s review and approval.
• Support Quality activities within transfers, launches and deals.
• Participate quality activities within global projects.

What you’ll bring to the role:
 

Essential Requirements:

• University degree in Microbiology, Biotechnology, Biochemistry or equivalent.
• 5-7 years of working experience in the pharmaceutical industry with direct experience in QA operations and Biologics.
• Excellent communication and organizational skills.
• Excellent skills in identifying issues and solving problems.
• Excellent & detailed knowledge of GMP-regulations (EMA; FDA, CA, etc). 
• Collaborating across boundaries.
• Project Management experience.
• Fluent in English.

You´ll receive:

• Attractive salary with incentive program
• Modern company pension scheme
• Flexible working hours / home-office depending on the position
• 14 weeks of paid parental leave
• Additional days off (bridge-days)
• Subsidized meals in our canteen
• Sustainable mobility in the form of company transportation, shift buses and car sharing
• Company Kindergarden and summer camps for children
• Wellbeing & mental health offers
• Learning and development options for your personal and professional growth
• 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 EUR 77.543,30 /year (on a full-time basis).

In most cases, however, 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.

Why Sandoz?

Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, provides more than 800 million patient treatments to over 700 million patients every 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 are 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!

Are you ready to join us? Then we look forward to your application!

Commitment to Diversity & Inclusion:

We are committed to building an outstanding, inclusive work environment and fostering diverse teams, that represent the patients and communities we serve.

If you require assistance during the application process due to a medical condition, physical disability, or a neurodiverse condition, please contact us at [email protected].

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 Talent Pool

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Skills Desired