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 our new Quality Assurance Manager, you will be responsible for overseeing all quality-related activities within your area of responsibility. You will ensure that operations comply with cGMP (Current Good Manufacturing Practices), the Quality Assurance Agreement, applicable regulatory requirements, and the Sandoz Quality Manual. All activities must be conducted in accordance with 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.
• Supplier relationship management:
  Build and proactively maintain strong strategic relationship with suppliers beyond issues escalation and resolution.
  Wherever needed, work with the supplier on a documented remediation plan and ensure systematic transition to ‘Trust’ status.
  Facilitate open communication, cooperation, and rapid issue resolution including managing non-performance with supplier.
  Identify and manage any supplier related risks and resolve conflicts / issues.
• Supplier performance management
  Drive supplier performance to improve KQIs through monitoring, evaluating and providing feedback to supplier on performance.
  Evaluate, approve investigations for critical Complaints & Deviations, address signals & trends and work with supplier to put appropriate measures in place to minimize recurrence.
  Assess the impact of Sandoz audit / HA inspection outcomes at supplier and ensure robust CAPAs and timely closure.
  Actively support to resolve Quality issues / conflicts with supplier to ensure timely Launches.
  Identify and collaborate to eliminate non-value-added tasks in interfacing QA activities with Supplier.
• Internal stakeholder management
  Provide visibility and regular updates to leadership & key stakeholders on topics of importance e.g. those impacting product quality and supply.
  Devise and implement action plans for quick resolution of stock out cases. Communicate in timely manner.
  Represent ESO QA in Global escalation calls and implement lessons learnt.
• ESO QA routine tasks
  Implement Supplier Qualification process to support timely launches. Support timely Tech transfers as per plan.
  Draft, negotiate, update Quality agreements, PSA / SSA with Suppliers.
  Initiate audit requests and perform timely closure of Audit CAPAs.
  Perform Risk assessment during exceptions management, as needed by HA.
  Initiate / evaluate / close change controls, as applicable.
  Approve CQRA and APQRs.

What you’ll bring to the role:

Essential Requirements:

• University degree in Natural Sciences (e.g., Chemistry, Pharmacy, Biotechnology, Biology).
• 10+ years in the pharmaceutical industry, with direct experience in sterile/aseptic manufacturing or quality.
• Expert knowledge of cGMP for sterile products, including EU GMP Annex 1 and US FDA regulations.
• Strong technical and regulatory understanding of sterility assurance and commercial manufacturing.
• Minimum 5 years in Quality Assurance, with broader experience in QA/QC, Production, or related areas.
• Proficient in managing key quality processes, such as exceptions, complaints, batch reviews, QAA, QRA, APQR.
• Effective communicator and stakeholder manager, comfortable in matrix organizations.
• Adaptable and performance-driven, with experience in leading improvement initiatives.
• Languages: English (Fluent)

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 65.605,54/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.

This salary and the associated benefits apply to Austria. If the position is filled in Slovenia, we will follow the country-specific market standards.

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 jobs.austria@sandoz.com.

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